cGMP and Regulatory Updates

1.0 OBJECTIVE To ensure that the incubator performs satisfactorily and maintain accurate temperature for Microbial growth. 2.0 SCOPE The SOP covers procedure for operation and calibration of incubator and is applicable to Quality Control Department formulation Units 3.0 RESPONSIBILITY Microbiologist. 4.0 ACCOUNTABILITY Department Head. 5.0 PROCEDURE 5.1 Ensure that the power supply to the incubator is switched ‘OFF’. 5.2 Dedust the incubator daily externally with a clean dry cloth. 5.3 Once a week remove adhered dust by wet mopping using detergent solution. Afterwards wipe the surface with a clean dry cloth to remove traces of detergent. 5.4 Once in a month clean the interior surfaces with 2.5 % savlon solution using a clean cloth. 6.0 OPERATING PROCEDURE 6.1 Ensure that the incubator is properly connected to the power supply. 6.2 Switch on the main . 6.3 Turn on the red colour power knob towards 0-1. ...

1.0 OBJECTIVE: To estimate Microbial Load in Production Area by Air sampling kit. 2.0 SCOPE This SOP is applicable to Quality Control Department (Microbiology Lab). 3.0 RESPONSIBILITY: Sr. Executive. 4.0 ACCOUNTABILITY : Department Head 5.0 PROCEDURE: 5.1 Take sampling kit to area where sampling to be carried out. 5.2 Remove the sampler from kit and open the backside lid . 5.3 Put batteries in the sampler and ensure that it is in working condition. 5.4 Put the sterilized hand gloves. 5.5 Remove the strip holder and sanitize the complete assembly by isopropyl alcohol (70% filtered through 0.2u membrane filter). 5.6 Remove agar strip from sealed sterile pouch and insert carefully into the strip holder. 5.7 Adjust the timer by a knob provided and set the time from 0 to 1 minute , 2 minute upto maximum 4 minutes. 5.8 Press starts button . 5.9 After completion of sampling remove the agar strip an...

1.0 OBJECTIVE: To determine the bioload ofbacteria ,yeast and molds and specific pathogens in raw material and finished products. 2.0 SCOPE This SOP is applicable to Quality Control Department (Microbiology Lab). 3.0 RESPONSIBILITY : Sr. Executive. 4.0 ACCOUNTABILITY : Department Head 5.0 PROCEDURE: 5.1 SAMPLE PREPARATION: 5.1.1 Total Aerobic Microbial Count : Use the plate method for substance that are sufficiently soluble or translucent to permit the use of method; otherwise, use the multiple tube method. 5.1.2 For Water Soluble Products : Dissolve 10 gms or 10 mL of substance in case of Raw material and 5gm or 5ml of finished product being examined in 100 mL, of soyabean casein digest medium and fluid lactose broth. A suitable surface active agents such as 0.1% w/v of polysorbate, may be added to assist the suspension of poorly wettable substances. 5.1.3 For Fatty Products : Homogenize 10gm or 10 mL of the preparation being examined with 5 gms of polysorbate 20, or polysorbate80. If...

1.0 OBJECTIVE To lay down a procedure for entrance in microbiology working area. 2.0 SCOPE This SOP is applicable to Quality Control Department Formulation Units 3.0 RESPONSIBILITY Microbiologist. 4.0 ACCOUNTABILITY Department Head. 5.0 PREPARATION OF DISINFECTANT SOLUTION. 5.1 Add 25 ml Dettol in 975 ml of purified water in S.S. Bowl to produce 2.5% solution. 5.2 Add 25 ml Savlon in 975 ml of purified water in S.S. Bowl to produce 2.5% solution. 5.3 Add 70ml isopropyl alcohol in 30 ml purified water in Bottle to produce 70% I.P.A. solution and filter through 0.45 micron membrane. 5.4 Daily prepare fresh Savlon and Dettol solution for cleaning and prepare 70% alcohol once a week. 6.0 PROCEDURE 6.1 Remove street shoes and Apron in Ist change room and cross the bench by sitting on it. 6.2 Wash the hands with the Savlon or dettol prepared as above. 6.3 Enter into the II nd change room And wear the steri...

1.0 OBJECTIVE To lay down the procedure to determine the efficacy of the disinfectants being used for house keeping activities. 2.0 SCOPE This SOP is applicable to the Quality Control Department (Microbiology Lab). 3.0 RESPONSIBILITY Microbiologist. 4.0 ACCOUNTABILITY Department Head. 5.0 PROCEDURE 5.1 Ensure that the availability of following material before start of analysis. 1) Pure cultures of Staphylococcus aureus ATCC 6538 & Pseudomonas aeruginosa ATCC 9027 2) Sterilized Conical flasks ( 250 ml capacity) 3) Sterilized graduated pipettes ( 1 ml ) 4) Sterilized Petriplates 5) Sterilized test tubes (18 x 150 mm) 6) Nutrient agar / Soya bean casein digest agar 7) Nutrient broth / Soya bean casein digest medium 8) Inactivating agent (Lecithin / Sodium thiosulfate/ Sodium thioglycollate) 5.2 Preparation of Inoculum: 5.2.1 Inoculate the organism in nutrient or soyabean casein digest medium and incubate at 37°C for 24 hours. Inocula...

1.0 OBJECTIVE To lay down the procedure for identification of the bacterial colonies obtained during the plate exposure in production area to know about the flora present in the production environment. 2.0 SCOPE This SOP is applicable to the Quality Control Department (Microbiology Lab). 3.0 RESPONSIBILITY Microbiologist/ Quality Control Executive 4.0 ACCOUNTABILITY Department Head. 5.0 PROCEDURE 5.1 Pick the individual colonies from the plates exposed in change rooms, secondary packing rooms and finished goods stores. 5.2 Purify the colonies, if necessary by streaking on to Soyabean casein digest agar plate. 5.3 Observe and record the morphological characters of the colonies such as shape, elevation, colour and margins in . Record all the observation. 5.4 Using sterile inoculating technique, inoculate the organism on two soyabean casein digest agar slants. Use one slant culture to determine the cultural characteristics and the ot...

1.0 OBJECTIVE To ensure that instrument performs satisfactorily and gives accurate and reproducible results. 2.0 SCOPE This sop is applicable to the Quality Control Department. 3.0 RESPONSIBILITY Quality Control Chemist/Executives 4.0 ACCOUNTABILITY Department Head. 5.0 GENERAL CLEANING PROCEDURE 5.1 Daily clean the external surface of the balance with dry mop immediately after use. 5.2 Once in a month clean the external surface with a wet mop dipped in 2.5 % savlon solution and ensure that no water goes into the balance while cleaning. 6.0 PROCEDURE : 6.1 Place the balance in a place which is free from excessive air currents, vibration and temperature extremes. 6.2 Keep the balance on a leveled work surface. 6.3 Make sure the hole in the pan support faces the rear of the balance and place the pan on the support making sure that the guide pin is inserted in the hole in the pan support. 6.4 Plug the molded connector of the adopter i...

1.0 OBJECTIVE To lay down the procedure for Operation and maintenance of Oil free vacuum pump . 2.0 SCOPE This sop is applicable to the Quality Control Department . 3.0 RESPONSIBILITY Microbiologist 4.0 ACCOUNTABILITY Department Head 5.0 GENERAL CLEANING PROCEDURE 5.1 Ensure that the power supply to the equipment is switched OFF before cleaning. 5.2 Dedust the equipment daily externally with a clean dry cloth. 5.3 Once in a week remove adhered dust by wet mopping using detergent solution. Afterwards wipe the surface with a clean dry cloth to remove traces of detergent. 5.4 Precaution has to be taken to clean the oven immediately with dry cloth to remove the moisture. 5.5 Once in a month clean the external surface with a wet mop dipped in 5 % Savlon solution and ensure that no water goes into the vacuum pump while cleaning. 6.0 PROCEDURE 6.1 Select the appropriately sized tube. 6.2 Prepare the necessary equip...

1.0 OBJECTIVE To lay down the operating procedure for Cyclomixer. 2.0 SCOPE This sop is applicable to the Quality Control Department. 3.0 RESPONSIBILITY Quality Control Chemist/ Microbiologist 4.0 ACCOUNTABILITY Department Head. 5.0 GENERAL CLEANING PROCEDURE 5.1 Daily clean the external surface of the cyclomixer with dry mop immediately after use. 5.2 Once in a month clean the external surface with a wet mop dipped in 2.5 % Savlon solution and ensure that no water goes into the cyclomixer while cleaning. 6.0 Procedure 6.1 Place the cyclomixer on a rigid flat level or bench which is free from Vibration. 6.2 Sufficient clear area must be available around the cyclomixer to allow uninterrupted rotation of rubber top. 6.3 Connect the power plug to a suitable power socket having proper earthing. 6.4 When the unit is connected to power supply the lamp will glow. 6.5 Put ‘ON’ the switch and control the speed by ro...

1.0 OBJECTIVE To lay down the procedure for operation and monitoring of Refrigerator. 2.0 SCOPE This sop covers the procedure for operation and monitoring of Refrigerator and is applicable for Quality Control Department 3.0 RESPONSIBILITY QC Chemist/ Microbiologist 4.0 ACCOUNTABILITY Department Head. 5.0 GENERAL CLEANING PROCEDURE 5.1 De dust the refrigerator daily externally with a clean dry cloth. 5.2 Once a week remove adhered dust by wet mopping using detergent solution . Afterwards wipe the surface with a clean dry cloth to remove traces of detergent. 5.3 Once in a month mop the interior surfaces with 2.5 % Savlon solution and then with a clean dry cloth. 6.0 OPERATING PROCEDURE 6.1 Ensure that the refrigerator is properly connected to the power supply, through a voltage stabilizer. 6.2 Switch ‘ON’ the main switch . 6.3 Keep the material in the fridge and close the door gently to avoid jerks. 6.4 Keep a ...

1.0 OBJECTIVE To lay down a procedure for finger dab test to check the cleanliness of personnel. 2.0 SCOPE This SOP is applicable to Quality Control Department. 3.0 RESPONSIBILITY Microbiologist 4.0 ACCOUNTABILITY Department Head 5.0 PROCEDURE 5.1 Prepare soyabean casein digest agar plates. 5.2 Take the plates to the test location. 5.3 Open the plate and ask the person to touch the agar surface with the fingers gently. 5.4 Close the plate quickly and bring to the lab. 5.5 Incubate soyabean casein digest agar plates at 30 - 35 OC for 3 days. 5.6 Count the number of colonies on each plate and record the observation. 6.0 FREQUENCY 6.1 Once a month 5 persons from each module.

1.0 OBJECTIVE To lay down a procedure for Swab Test of Linen. 2.0 SCOPE This SOP covers the procedure for Swab Test of Linen and is applicable to Quality Control Department 3.0 RESPONSIBILITY Microbiologist 4.0 ACCOUNTABILITY Department Head. 5.0 PROCEDURE 5.1 Prepare absorbent cotton swab or ready made sterile swabs can be used. 5.2 Keep the prepared swab in test tube containing 1 to 2 ml normal saline. (Ensure that the swab gets moistened.) Ready made swabs can be used directly as such. 5.3 Sterilize the containers along with the swabs at 15 lb, 121 OC for 20 min. 5.4 Swab about 2 x 2 sq. inch area of the linen with two sterilized cotton swabs . And immerse the swab in test tube containing 10 ml of sterile normal saline. 5.5 Streak one of the swab from all the sides on the surface of the soyabean casein digest agar plate and the other on the surface of sabourauds dextrose agar plates. 5.6 Incubate soyabean case...

1.0 Objective To estimate Microbial Load in Production Area. 2.0 SCOPE This SOP is applicable to Quality Control Department (Microbiology Lab). 3.0 Responsibility Microbiologist 4.0 Accountability Department Head 5.0 PROCEDURE 5.1 Plate Exposure method : 5.1.1 Prepare Soyabean Casein Digest agar (SCDA) and Sabouraud Dextrose agar (SDA)plates as per the current version of sop no. 32QC071 . 5.1.2 Incubate the plates for 24 hours at 37°C. 5.1.3 Carry the plates to production area for exposure. 5.1.4 Put the hand gloves and Clean the surface and outer side of plate by 70% isopropyl alcohol. 5.1.5 Open the plate carefully and keep it asper the time maintioned bellow . 5.1.6 Duration of Exposure : 30 minutes under working condition. 60 minutes under non-working condition. 5.1.6 After specified period of exposure, close the plates carefully and bring back to QC lab and incubate SCD agar plates at 37°C and SD agar plates at 22° C. plates after 5 days for colony forming units . Count colonies a...

1.0 OBJECTIVE To lay down a procedure for microbial count in microbiology area. 2.0 SCOPE This sop is applicable to Quality Control Department(microbiology lab). 3.0 RESPONSIBILITY Microbiologist 4.0 ACCOUNTABILITY Department Head 5.0 PROCEDURE 5.1 Prepare Soyabean Casein Digest Agar plates and Sabouraud’s Dextrose Agar Plates as per the current version of sop no. 32QC071. 5.2 Expose one soyabean casein digest agar plates and sabouraud’s dextrose agar plate as per the annexure-I for time specified as given below: a. Critical area (i.e., on LAF bench) : 60 min b. In other areas : 30 min. 5.3 Incubate the soyabean casein digest agar plates at 37OC and sabouraud dextrose agar plates at 22OC for 5 days. 5.4 Record the result as per annexure- I 5.5 Microbial Limits (CFU/Plate) 6.0 FREQUENCY 6.1 Once a Week and after every maintenance job.

1.0 OBJECTIVE To lay down a procedure for Fumigation of Microbiology Lab. 2.0 SCOPE This SOP is applicable to Quality Control Department (Microbiology Lab). 3.0 RESPONSIBILITY Microbiologist 4.0 ACCOUNTABILITY Department Head. 5.0 PROCEDURE 5.1 Use safety goggles and hand gloves during fumigation. 5.2 Put ‘OFF’ the A/C unit . 5.3 Take Potassium Permanganate (about 15 gm.) in a petri dish and keep in the area where fumigation is to be carried out. 5.4 Place the petri plate on a polyethene bag. 5.5 Add about 25 ml of 35 % Formaldehyde solution to Potassium Permanganate . 5.6 Immediately close the area. 5.7 Label the area as “Area Under Fumigation” so that nobody enters the room. 5.8 Keep the room under fumigation for a minimum of 8 - 12 hrs. 5.9 Defumigate the room by putting on the A/C unit . 6.0 FREQUENCY : 6.1 once a week and after completion of any civil work. Hazards of Formaldehyde : 1. It is toxic to inhalation and ingestion and causes irritation to eyes and respiratory tract. 2. ...

1.0 OBJECTIVE To lay down the procedure for swab sampling of test surfaces for validation 2.0 SCOPE This SOP is applicable to Quality Control Department . 3.0 RESPONSIBILITY Microbiologist. 4.0 ACCOUNTABILITY Department Head. 5.0 PROCEDURE 5.1 MATERIAL & REAGENTS SWAB : Sterilized Johnson’s bud/Hi-media’s sterile cotton swab TRANSPORT CONTAINER : Capped test tubes made of glass/ cotton plugged test tubes SAMPLING SOLVENT : Sterile Normal Saline. 5.2 SWAB SAMPLING PROCEDURE 5.2.1 Remove a swab from it’s protective bag using a clean latex hand glove. 5.2.2 Avoid touching the swab head to prevent it’s contamination. 5.2.3 Transfer the swab in transport container (test tube) containing 10 ml of sterile saline and allow the swab to soak completely. 5.2.4 Take out the swab from water and squeeze the tip against inner surface of test tube to remove excess water in such a manner that excess water drips inside the ...

1.0 OBJECTIVE To lay down a procedure for preparation of culture media. 2.0 SCOPE This SOP covers the procedure for preperation of culture media and is applicable to Quality Control Department 3.0 RESPONSIBILITY Microbiologist. 4.0 ACCOUNTABILITY Department Head 5.0 PROCEDURE 5.1 Store dehydrated media in tightly closed bottles in the dark or as directed by manufacturer. 5.2 Follow the manufacturers direction for rehydration . 5.3 Check pH of the medium after rehydration and if necessary adjust the pH. 5.4 After rehydrating the medium dispense promptly into labeled flasks or tubes and cover with metal caps / plastic caps/ cotton plugs and wrap in butter paper and sterilize within two hours as per the manufacturers instructions. 5.5 Incubate the sterilized media for 24 hrs. before use at the appropriate temperature to check the contamination if any. 5.6 Store the media below 25 OC after pre-incubation and use...

1.0 OBJECTIVE To lay down a procedure for line clearance of packing material dispensing area. 2.0 SCOPE Primary and Secondary packing material dispensing area. 3.0 RESPONSIBILTY Production officer. 4.0 ACCOUNTABILITY Production Executive . 5.0 PROCEDURE 5.1 Check for the cleanliness of area and record the same in the checklist. (Annexure-I). 5.2 Inspect the dispensing area and thoroughly check for any left-overs of previous batch. 5.3 If all the points in check list is complied, then line clearance to be certified signing the check list. 5.4 The checklist should be preserved along with the Batch Packing Record. ANNEXURE –I

1.0 OBJECTIVE To lay down a procedure to check the points to be followed during dispensing operation of packing materials. 2.0 SCOPE Primary and secondary packing material dispensing area. 3.0 RESPONSIBILTY Production officer. 4.0 ACCOUNTABILITY Production Executive. 5.0 PROCEDURE 5.1 Check the following points during dispensing operation. 5.2 Check the balance for cleanliness, its zero error and calibration as per SOP. No: xxxxxx 5.3 Ensure FIFO system is followed for dispensing. 5.4 Ensure that every container / package is having quality control approved label. 5.5 Ensure that the primary packing materials such as printed foil, plain foil, PVC film, PVDC film, are placed in poly bag after dispensing and before taking for packing. 5.6 Ensure each dispensed material is properly labelled and need to be preserved along with the batch packing record. Ensure that cartons, catch covers, leaflets, sh...

1.0 OBJECTIVE To lay down a procedure to check the points to be followed during dispensing operation of raw material. 2.0 SCOPE Raw Material Dispensing area I & II. 3.0 RESPONSIBILTY Production officer. 4.0 ACCOUNTABILITY Production Executive. 5.0 PROCEDURE 5.1 Check the following points during dispensing operation. 5.1.1 Check that materials dispensed are as per FIFO method. 5.1.2 Cross- check the values of moisture content and assay of each active ingredient against the A.R.No from SAP. 5.1.3 Check that the non – actives are dispensed first, followed by actives. 5.1.4 Ensure that double poly bags are used for dispensing. 5.1.5 Ensure dedicated marked and cleaned scoops are used for dispensing of active ingredients. 5.1.6 Ensure separate cleaned scoops are used for different non- actives. 5.1.7 Check for QC approved (Green) status label and the re-testing date on the container. 5.1.8 Check ...

1.0 OBJECTIVE To lay down a procedure for line clearance of raw material dispensing area. 2.0 SCOPE Raw material Dispensing area I & II. 3.0 RESPONSIBILTY Production officer / QA officer. 4.0 ACCOUNTABILITY Production Executive / QA Executive. 5.0 PROCEDURE 5.1 Check for the cleanliness of area and record the same in the checklist. (Annexure-I). 5.2 Inspect the dispensing area and thoroughly check for any visible contamination of previous product as per the checklist. 5.3 Recommend rewash, if visible contamination from the previous product is noticed. 5.4 If all the points in checklist is complied, then line clearance to be certified signing the check list. 5.5 The checklist should be preserved along with the Batch Manufacturing Record. ANNEXURE –I

1.0 OBJECTIVE To lay down a procedure for marking of Finished product Shippers (Export.) 2.0 SCOPE All Packing Halls 3.0 RESPONSIBILITY Production officer. 4.0 ACCOUNTABILITY Production Executive. 5.0 PROCEDURE 5.1 As per packing instructions given in the BPR the final shippers are over printed with Product, Batch No, Consignment details by klass marking and the same proof is marked in BPR. Export labels are pasted as per the party requirement before dispatch from the factory

1.0 OBJECTIVE To lay down a procedure for cleaning, calibration & operation of the analytical balance (METTLER AR 104). 2.0 SCOPE Module-4. 3.0 RESPONSIBILITY Production officer. QA chemist. 4.0 ACCOUNTABILITY Production Executive. 5.0 PROCEDURE 5.1. Cleaning. 5.2. Calibration. 5.3. Operation. 5.4 Shut down. 5.1 Cleaning 5.1.1 Ensure that the power supply to the balance is switched ‘off’ before cleaning. 5.1.2 Clean the pan and inside of the balance with brush. 5.4.1 Clean the outside of the balance with clean and dry lint free duster every day. 5.2 Calibration 5.2.1 Frequency of calibration 5.2.2 Self Calibration Procedure Frequency daily and after each maintenance job. 5.2.2.1 Clean the balance as per procedure given in 5.1 5.2.2.2 Check that air bubble is at the center of the level indicator and if required adjust the level by turning the leveling screws. 5.2.2.3 Switch on the balance and allow it...

1.0 OBJECTIVE To lay down a procedure for defining Pre Determined Frequency for various operational activities in Water system. 2.0 SCOPE This SOP is applicable to Formulations Units 2.1.0 AREAS 2.1.1 DM plant and UWF. System. 3.0 RESPONSIBILITY Jr. Technical Officer / Executive –production/ Officer –Production. 4.0 ACCOUNTABILITY Manager - Production 5.0 PROCEDURE 5.1.0 Frequency Chart Backwash of sand filter - Daily 5minutes before starting the operation. Backwash of activated carbon filter - Daily 5minutes before starting the operation. Sanitization of purified water supply loop - Once in 7 days. Sanitation of UWF by hydrogen peroxide - Once in 15 days. Regeneration of Cation , Anion and Mixed bed - If the conductivity of Anion outlet water exceeds 20 µs / cm and conductivity of mixed bed outlet water exceeds 1 µs / cm. Changing of 5mm filter in DM Plant - Once in 6 months. Changing of 3mm filter in purified water plant - Once in 6 mo...

1.0 OBJECTIVE To lay down a procedure for operation of pH­ meter (Model pH scan-2). 2.0 SCOPE This SOP is applicable to Formulations Units 2.1.0 AREAS 2.1.1 D.M. plant. 3.0 RESPONSIBILITY Jr. Technical Officer / Executive (production) 4.0 ACCOUNTABILITY Manager - Production 5.0 PROCEDURE 5.1.0 Precautions 5.2.0 Pre Startup 5.3.0 Calibration 5.4.0 Operation. 5.1.0 Precautions 5.1.1 Do not dip the pH meter more than the minimum immersion level. 5.1.2 E1 on display indicates, “Ensure that the battery is changed”. 5.2.0 Pre Startup 5.2.1 Ensure the cap of pH meter is removed. 5.2.2 Ensure the pH meter is calibrated before usage. 5.3.0 Calibration 5.3.1 Calibration to be done with the help of standard buffer solutions of pH 4, 7 and 10. 5.3.2 Calibrate initially with buffer solution of pH 7. 5.3.3 Select a standard buffer of pH 7. 5.3.4 Press the ON/OFF button on the key pad to turn on the pH meter. 5.3.5 Press the “CAL” button to enter calibration mode. ...

1.0 OBJECTIVE To lay down a Procedure for Setup, Operation & Cleaning of Jet cleaner. 2.0 SCOPE Module – 1,2,3,4&5. 3.0 RESPONSIBILITY Operator Concerned. 4.0 ACCOUNTABILITY Officer / Executive - Production 5.0 PROCEDURE 5.1 Precautions 5.2 Setup 5.3 Operation. 5.4 Cleaning 5.5 Shut down. 5.1 Precautions 5.1.1 Ensure the wheels of Jet cleaner are moving freely. 5.1.2 Never switch ‘ON’ the heater without water. 5.1.3 Remove the power plug from the socket before cleaning. 5.2 Setup 5.2.1 Switch on the mains. 5.2.2 Close the outlet valves of water tanks. 5.3 Operation 5.3.1 Fill both the tanks with potable water and cover with lids. 5.3.2 Ensure the level of water in tanks, is not up to the brim. 5.3.3 Switch on the heater , wait till required temperature is reached. 5.3.4 Switch OFF the heater. 5.3.5 Pres...

1.0 OBJECTIVE To lay down a procedure for changing of Air vent filters in Ultra Filtration room. 2.0 SCOPE This SOP is applicable to Formulations Units 2.1.0 AREAS 2.1.1 Purified water plant. 3.0 RESPONSIBILITY Technical officer / Executive (production) 4.0 ACCOUNTABILITY Manager - Production 5.0 PROCEDURE 5.1.0 Precautions 5.2.0 Operation. 5.1.0 Precautions 5.1.1 Be careful while handling the filter cartridge. 5.2 Operation 5.3.1 For C.I.P tank vent filter remove the Tri Clover Clamp. 5.3.2 Remove the air vent filter from its base. 5.3.3 Reposition the new air vent filter. . 5.3.4 Tight the Tri Clover Clamp. 5.3.5 For storage tank remove the Tri Clover clamp. 5.3.6 Keep the entire filter housing down. 5.3.7 Remove the filter housing Tri Clover clamp. 5.3.8 To remove air vent cartridge rotate it on clock wise direction. 5.3.9 Put the new cartridge in position rotate it in anti clock wise...

1.0 OBJECTIVE To lay down a procedure for changing of 3mm filter in purified water plant. 2.0 SCOPE This SOP is applicable to Formulations Units 2.1.0 AREAS 2.1.1 Purified water plant. 3.0 RESPONSIBILITY Technical officer / Executive (production) 4.0 ACCOUNTABILITY Manager - Production 5.0 PROCEDURE 5.1.0 Precautions 5.2.0 Pre-start up 5.3.0 Operation. 5.1.0 Precautions 5.1.1 Be careful while handling the filter cartridge. 5.2.0 Pre-start up 5.2.1 Stop the De-gasser pump. 5.2.2 Close the valves V-8. 5.3 Operation 5.3.1 Remove the Tri Clover clamps and kept the filter housing down. 5.3.2 Remove the filter housing Tri Clover clamp. 5.3.3 Remove the filter cartridge from its base . 5.3.4 Fit the new filter housing on its base. 5.3.5 Reposition the filter housing on its base. 5.3.6 Tight the filter housing Tri Clover clamp. 5.3.7 Put the filter in its original position then tighten the Tri Clover clamps.

1.0 OBJECTIVE To lay down a procedure for Defouling treatment of cation and anion resines. 2.0 SCOPE This SOP is applicable to Formulations Unit 2.1.0 AREAS 2.1.1 D.M. water plant. 3.0 RESPONSIBILITY Technical officer / Executive (production). 4.0 ACCOUNTABILITY Manager production. 5.0 PROCEDURE 5.1 Precautions 5.2 Pre – Start up 5.3 Operation 5.1 Precautions 5.1.1 Use correct size spanner while loosing bolts and nuts. 5.1.2 Be careful while removing top dish and top strainer plate. 5.1.3 Use acid & alkali proof hand gloves and nose mask before handling Hcl & NaoH. 5.2 Pre-Start up 5.2.1 Stop all the pumps (Raw water, De-gasser pumps). 5.2.2 Open the valve No:6 (C.B.V 6 and A.B.V 6 for cation and anion beds respectively ) to drain the water in side the vessel. 5.2.3 Ensure the availability of chemicals (Hcl, NaoH, Nacl). 5.2.4 Ensure the availability of Raw water. 5.3 Operation 5.3.1 Remove the top di...

1.0 OBJECTIVE To lay down a procedure for changing of 5micron filter in D.M plant . 2.0 SCOPE This SOP is applicable to Formulations Units 2.1.0 AREAS 2.1.1 D.M. water plant. 3.0 RESPONSIBILITY Technical officer / Executive (production). 4.0 ACCOUNTABILITY Manager – Production. 5.0 PROCEDURE 5.1.0 Precautions. 5.2.0 Pre-start up . 5.3.0 Operation. 5.1.0 Precautions 5.1.1 Be careful while handling the filter cartridge. 5.2.0 Pre-start up 5.2.1 Stop the De-gasser pump. 5.2.2 Close the valves M.B.V –1 and M.B.V –2. 5.2.3 Open the drain plug to drain the water in side the housing. 5.3 Operation 5.3.1 Remove the T.C clamp. 5.3.2 Remove the filter housing. 5.3.3 Remove the filter cartridge from its base by removing the top nut. 5.3.4 Kept the new filter cartridge on its base and then tighten the top nut. 5.3.5 Reposition the filter housing. 5.3.6 Tight the T.C clamp. Tight the drain plug.

1.0 OBJECTIVE To lay down a procedure for Changing the D.M Water plant resins. 2.0 SCOPE This SOP is applicable to Formulations Units. 2.1.0 AREAS 2.1.1 D.M. water plant. 3.0 RESPONSIBILITY Technical officer / Executive (production) 4.0 ACCOUNTABILITY Manager production. 5.0 PROCEDURE 5.1 Precautions 5.2 Pre – Start up 5.3 Operation 5.1 Precautions 5.1.1 Use correct size spanner while loosing bolts and nuts. 5.1.2 Be careful while removing top dish and top strainer plate. 5.1.3 Use suitable chain block to lift the vessle. 5.2 Pre-Start up 5.2.1 Stop all the pumps (Raw water, De-gasser pumps). 5.2.2 Open the valve No:6 or 10 (C.B.V 6 and A.B.V 6 for cation and anion beds respectively M.B.V 10 for mixed bed) to drain the water in side the vessel. 5.3 Operation 5.3.1 Remove the top dish bolts and nuts using the spanner No: 26. 5.3.2 Keep the top dish on ground and then strainer plate. 5.3.3 R...

1.0 OBJECTIVE To lay down a procedure for cleaning of UF membrane. 2.0 SCOPE This SOP is applicable to Formulations Units 2.1.0 AREAS 2.1.1 Purified water plant. 3.0 RESPONSIBILITY Technical officer / Executive (production) 4.0 ACCOUNTABILITY Manager production. 5.0 PROCEDURE 5.1 Precautions 5.2 Pre – Start up 5.3 Operation 5.1 Precautions 5.1.1 Be careful while handling the chemicals. 5.1.2 Wear gloves and nose mask before handling the chemicals. 5.2 Pre-Start up 5.2.1 Ensure the availability of D.M water. 5.2.2 Ensure the availability of all chemicals and accessories. 5.2.3 Ensure the availability of compressed air. 5.3 Operation 5.3.1 Ensure the pump P1 is in off position during cleaning. 5.3.2 Collect 600 lts (1250. Mm WC) of DM water in CIP tank. 5.3.3 Collect the valve V14, V17, V20, V21, V23, V27, V28, V31,V V52 & V67. 5.3.4 Open valve V15, V16, V18, V19 & V 29, 5.3.5 D...

1.0 OBJECTIVE To lay down a procedure for changing of UF membrane. 2.0 SCOPE This SOP is applicable to Formulations Units. 2.1.0 AREAS 2.1.1 Purified water plant. 3.0 RESPONSIBILITY Technical officer / Executive (production) 4.0 ACCOUNTABILITY Manager – Production 5.0 PROCEDURE 5.1.0 Precautions 5.2.0 Pre-start up 5.3.0 Operation. 5.1.0 Precautions 5.1.1 Be careful while handling the membrane. 5.1.2 Wear gloves while handling the membrane. 5.2.0 Pre-start up 5.2.1 Ensure the availability of Hydrogen Peroxide 5.3.0 Operation 5.3.1 Frequency: 5.3.1.1 If the microbial counts are above the alarming limits even after chemical sanitization. 5.3.1.2 Changing of UF membrane shall be done when the output of purified water reduced to below 900 lts / hour even after cleaning the membrane. 5.3.2 Stop pump P1 5.3.3 Close valves V16 and open valve V17 to drain the water ins...

1.0 OBJECTIVE To lay down a procedure for Chemical sanitization of purified water system loop when the microbial limits are above alarming range. 2.0 SCOPE This SOP is applicable to Formulations Units 2.1.0 AREAS Purified water plant. 3.0 RESPONSIBILITY Technical officer / Executive (production) 4.0 ACCOUNTABILITY Manager production. 5.0 PROCEDURE 5.1 Precautions 5.2 Pre – Start up 5.3 Operation 5.1 Precautions 5.1.1 Be careful while handling the chemicals. 5.1.2 Wear gloves and nose mask before handling the chemicals. 5.2 Pre-Start up 5.2.1 Ensure the availability of D.M water & Purified water. 5.2.2 Ensure the availability of all chemicals and accessories. 5.2.3 Before starting the pumps P2 / P3 make sure that all user point valves should be closed. 5.3 Operation 5.3.1Collect 600 lts of purified water into 1500 lts storage tank. Keep the U.F system in re-circulation mode by opening the valve V24 and closing the valve V23. 5.3.2 Pour 15 kgs of NaoH (100%)in the tank th...

1.0 OBJECTIVE To lay down a procedure for exit for visitors leaving from a) Pharma production b) Ware house (Raw and primary packing materials) c) Primary packing / Secondary packing area. 2.0 SCOPE Applicable to all the personnel who are leaving the areas mentioned in objective. 3.0 RESPONSIBILITY Concerned person 4.0 ACCOUNTABILITY PERSONS: Visitors ACCOUNTABILITY: Concerned company official accompanying the visitor. 5.0 PROCEDURE 5.1.0 Precautions 5.2.0 Exit procedure. 5.1.0 Precautions 5.1.1 All visitors should leave the pharma manufacturing area through the specified visitors change room only. 5.2.0 Exit procedure 5.2.1 Enter visitor change room. 5.2.2 Remove disposal shoe covers while crossing the step over bench and put them in the waste bin. 5.2.3 Remove the apron and headgear and deposit them in the used linen container provided. 5.2.4 Open the door and leave the change room

1.0 OBJECTIVE To lay down a procedure for primary dress change for visitors entering into a) Pharma production b) Ware house (Raw and primary packing materials) c) Primary packing / Secondary packing area. 2.0 SCOPE Applicable to all the personnel who are entering into the areas mentioned in objective 3.0 RESPONSIBILITY Concerned Person 4.0 ACCOUNTABILITY S.N0 1. PERSONS Visitors ACCOUNTABILITY Concerned company official accompanying the visitors. 5.0 PROCEDURE 5.1.0 Precautions 5.2.0 Entry Procedure. 5.1.0 Precautions 5.1.1 All visitors entering in to the manufacturing areas should be accompanied by a company official always. 5.1.2 There is a separate entry available for Visitors. 5.1.3 Any visitor who wants to enter into pharma manufacturing areas, (external corridors of modules, dispensing rooms, raw materials stores, hold rooms, primary packing areas and secondary packing areas) should enter through the specified change room only. 5.1.4 En...

1.0 OBJECTIVE To lay down a procedure for Reprocessing of batches. 2.0 SCOPE Module -1,2,3&5 3.0 RESPONSIBILITY Production Executive. 4.0 ACCOUNTABILITY Production Manager / QA Manager 5.0 PROCEDURE 5.1.1 If the specified standards are not meeting at granulation stage / pelletisation stage / coating stage or not meeting analytical standards such as Dissolution, Physical appearance, Assay, Moisture content, the Batch will be taken up for reprocessing. 5.1.2 Reprocessing of batch shall be done as per procedure. 5.1.3 An investigation will be done by the concerned production Executive for the reasons and a report will be sent to Formulations Research & Development. 5.1.4 Formulations Research & Development after studying the report shall recommend a reprocessing procedure. 5.1.5 Based on Formulations Research & Development suggestion a process deviation form will be raised by production department for approval . The same deviation should be appr...

1.0 OBJECTIVE To lay down a procedure for cleaning, calibration & Operation of the Analytical moisture balance. 2.0 SCOPE Module-x 3.0 RESPONSIBILITY Production Officer / QA chemist. 4.0 ACCOUNTABILITY Production Executive . 5.0 PROCEDURE 5.1 Cleaning 5.2 Calibration 5.3 Operation 5.4 Shut down. 5.1 Cleaning 5.1.1 Ensure that the power supply to be moisture balance is switched off before cleaning. 5.1.2 Lift the body & clean inside of the moisture balance with brush. 5.1.3 Clean the out side of the moisture balance with clean & dry lint free duster every day. 5.2 Calibration 5.2.1 Frequency of calibration. 5.2.1.1 Frequency daily & after each maintenance job. 5.2.2 Self calibration procedure. 5.2.2.1 Clean the balance as per procedure given in 5.1 5.2.2.2 Check that air bubble is at the center of the level indicator & if required adjust the level by turning the leveling screws. 5.2.2.3 ...

1.0 OBJECTIVE To lay down a procedure for labeling of containers, equipment’s accessories and areas at various stages. 2.0 SCOPE Raw material stores, Module -1,2,3,4,5, hold areas, all packing areas and packing material stores. 3.0 RESPONSIBILITY Concerned operator. 4.0 ACCOUNTABILITY: Production officer, stores assistant. 5.0 PROCEDURE 5.1 Precautions 5.1.1 While sticking, ensure that labels contents are clearly visible. 5.1.2 Put the labels for SS-316 inprocess containers in specified place only. 5.2.0. Procedure List of the labels used in production & ware house is given below. 5.2.1 Dispensing. 5.2.2 Quarantine label. 5.2.3 Do not use To be cleaned. 5.2.4 Cleaned. 5.2.5 Recoverable residues 5.2.6 Status label. 5.2.7 Stock return. 5.2.8 On-line rejection. 5.2.1 Dispensing. 5.2.1.1 Stores Asst. shall prepare the dispensing label and sign for weighed by and production officer shall check and sign for checked by. 5.2.1.2 Take...

1.0 OBJECTIVE To lay down a procedure for handling of inprocess containers (I.P.C’s) & H.D.P.E. containers. 2.0 SCOPE Module -1,2,3,4,5, hold areas, primary packing areas and dispensing areas. 3.0 RESPONSIBILITY Production officer. 4.0 ACCOUNTABILITY Executive – Production. 5.0 PROCEDURE 5.1 Handling of S.S 316 containers. 5.2 Handling of HDPE containers. 5.1 Handling of S.S 316 containers. 5.1.1 Clean the SS -316 containers with potable water jet by scrubbing with lint free duster or plastic scrubber, use nylon brush to clean the butterfly valve. 5.1.2 Clean the lids with potable water jet. 5.1.3 Finally rinse the containers and lids with purified water jet. 5.1.4 Dry the containers and lids with lint free duster. 5.1.5 Keep cleaned SS 316 containers with “CLEANED” label in the dispensed material hold room for dispensing. 5.1.6 Ensure that wheels of the containers are moving freely. 5.1.7 Take the containers for dispensing. 5.1.8 Before dispensing...

Prospective Validation - Design and Code Phase During this phase of the life-cycle, the design is documented, verified by a design review, and the system coding/configuration performed against pre-determined standards. Design specifications may take a variety of forms. Diagrams should be used where appropriate to assist readability. Where large systems are being developed it is permissible to split the design specifications into a number of separate documents. Where this approach is adopted, effective change control must be implemented to ensure that the effect of changing one component on others is fully assessed. Contents of the design specification should be cross-referenced to the system and functional requirements to demonstrate traceability. System Overview There should be a single document (clear, concise, accurate and complete) describing the purpose and function of the system. The system overview should be written in non-technical language so that personnel not trained in comp...

Prospective Validation - Requirements Phase Business requirements are further developed to produce what is commonly called a user requirements specification (URS). The URS should focus on what the system should do and not to detail how to achieve this, i.e. design statements should not be incorporated. For large and complex systems, a number of URSs may be required. For small and simple systems the business requirements and URS may be combined. The URS provides a statement of process/functional requirements of the proposed system. Each requirement should be categorised in order to define the level of importance, e.g. must, should, and could. All URS requirements should be successfully validated before system use unless otherwise justified and approved. Each URS requirement should be: • Referenced to facilitate requirements tracking (Requirements Traceability Matrix [RTM]). • Unambiguous, clear and concise. • Testable/measurable. • Be approved by the end-user. The URS provides the basis...

Prospective Validation - Supplier Assessment Phase Supplier assessments determine the level of assurance in the supplier that activities / deliverables equivalent to those outlined in this guideline have been followed/produced for development of computerised systems. The information is used to determine any corrective/additional activities to be undertaken by the supplier in order to address identified deficiencies. The need for follow-up supplier assessments should be commensurate with the number and severity of the identified deficiencies. The validation plan should document applicability and timing of supplier audits. The system category (Managing Hardware and Software) will assist in deciding when an audit is necessary. Supplier audits are most beneficial if they are conducted as part of the supplier selection and procurement process so that any actions arising can be planned and managed as part of the project implementation. Key areas of assessment are: • Existence and authority o...

Prospective Validation - Planning Phase Business Requirements This high level document describes the functions to be carried out, the operating environment and constraints, regulatory or otherwise. The emphasis is on the required functions and not the method of implementation and should therefore not be product specific. The business requirements will often document the business case and approval for work and capital investment. The approved business requirements should provide sufficient information for the compliance assessment and system selection activities to be completed. Compliance Assessment All computerised systems should be assessed during the early planning phase to determine if there is a GxP impact and, therefore, whether the system should be validated or not. The compliance assessment should be approved by QA/Validation. The Compliance Assessment should include a review of COTS product license requirements and release notes in order to determine any impact/restrictions on...

Prospective Validation Validation of computerised systems requires careful planning to identify the set of validation activities required from initial design through to implementation use and final decommissioning. In practice it can be impossible to validate existing systems where initial design requirements are no longer available or appropriate activities were not performed or documented as the system was designed and implemented. The forthcomming posts in this topic describe the validation activities appropriate to a new system. However, these life-cycle requirements should be considered when attempting retrospective validation of existing systems. The validation life-cycle activities and their order should be documented in a validation plan. A description of each phase of the life-cycle validation activities will be presented in the forthcomming posts as a sequential process, however certain activities may overlap or be combined. The validation plan should define such overlaps an...

1.0 OBJECTIVE To lay down a procedure for product change over in modules and primary packing areas. 2.0 SCOPE Module 1,2,3 and primary packing areas. 3.0 RESPONSIBILITY Production Officer. 4.0 ACCOUNTABILITY Executive / Sr. Executive - Production 5.0 PROCEDURE 5.1 The term “ product change over” denotes whenever an another product is to be taken for manufacturing, primary packing in an area / equipment which were used for the other product. 5.2 Remove the previous product and all accessories like punches and dies, FBD bags, FBD bowl covers from the module and transfer them to the quarantine area. 5.3 Arrange for cleaning of equipments for product to product changeover as per the respective SOP’s. 5.4 Send T.I sheet to QC through QA for swab sampling and analysis. Note: (For the products where cleaning validation is not completed.) 5.5 Ensure that all the equipments are cleaned. 5.6 Arrange for cleaning of all the process areas by house...