cGMP and Regulatory Updates

1.0 OBJECTIVE To lay down a procedure to keep all production areas free from traces of previous Batch of same Product and Strength. 2.0 SCOPE This SOP is applicable to Pharmaceutical Production area 2.1 AREAS Dispensing 1,2 , Module -1,2,3 and Packing Machine rooms. 3.0 RESPONSIBILITY Concerned Operator 4.0 ACCOUNTABILITY Production Officer. 5.0 PROCEDURE 5.1.0 Precautions 5.2.0 Equipments and Tools 5.3.0 Cleaning agents. 5.4.0 Disinfectants 5.5.0 Operation 5.1.0 Precautions 5.1.1 While cleaning the walls and floor do not use strong smelling disinfectants. 5.2.0 Equipments and Tools: 5.2.1 Vacuum cleaner 5.2.2 Scrubbing machine 5.2.3 Ordinary mop. 5.2.4 Lint free duster. 5.2.5 Glass cleaning cloth 5.2.6 Sponge rectangular. 5.2.7 Aluminium ladder of suitable size 5.3.0 Cleaning agents: 5.3.1 Alklean as is 5.3.2 Window shine glass...

1.0 OBJECTIVE To lay down a procedure for maintenance of dies and punches. 2.0 SCOPE Module –2,3,4 3.0 RESPONSIBILITY Concerned operator. 4.0 ACCOUNTABILITY Production officer. 5.0 PROCEDURE 5.1 Get required number of punches and dies from Quarantine and make necessary entries in punches and dies stock card and get it checked by production officer. 5.2 Transfer the required punches and dies to the compression area. 5.3 Remove punches from plastic cover and wipe out the oil adhering to the punches and dies. 5.4 Set up and fix punches and dies as per the SOP of compression machine change over operation. 5.5 If any abnormal sound is observed during compression, immediately stop the compression machine to avoid punches and dies damage and inform production officer. 5.6 Examine critically the punches and dies, remove the damaged punches and dies if any from the machine and replace them. 5.7 Remove the punches and dies after the com...

1.0 OBJECTIVE To lay down a procedure for cleaning of HDPE pallets. 2.0 SCOPE Module -1,2,3,4,5 and raw material stores. 3.0 RESPONSIBILITY Production officer / Stores assistant. 4.0 ACCOUNTABILITY Production executive. 5.0 PROCEDURE 5.1 Frequency:- Once in a month (or) when ever necessary. 5.2 Bring the pallet to the washing area. 5.3 Clean the pallets by wiping with lint free duster from all sides. 5.4 Clean with 0.1% teepol solution by using nylon brush. 5.5 Wipe the pallet with wet lint free duster after washing with potable water jet. 5.6 Wipe the cleaned pallet with dry lint free duster.

1.0 OBJECTIVE To lay down a procedure for cleaning of in-process containers. 2.0 SCOPE Module - 1,2,3,4 and 5. 3.0 RESPONSIBILITY Production officer. 4.0 ACCOUNTABILITY Production executive 5.0 PROCEDURE 5.1 After usage of the Inprocess container replace the label with “ TO BE CLEANED” label. 5.2 Transfer the container to washing room. 5.3 Remove the “TO BE CLEANED ” label and preserve it with next batch / product document. 5.4 Clean the container by wiping with lint free duster, from outside. 5.5 Clean the container with potable water jet using lint free duster . 5.6 Rinse with purified water jet. 5.7 Dry the container with lint free duster. 5.8 Ensure putting back the same lid to the container. 5.9 Label it as “ CLEANED” with checked by sign and date. In case of product change over: -Clean the containers with potable water jet/ hot water using lint free duster. -Finally rinse the container with pur...

1.0 OBJECTIVE Procedure for correction of wrong entries in BMR / BPR. 2.0 SCOPE Module - 1,2,3,4,5, Stores and all Packing areas. 3.0 RESPONSIBILITY Production officer. 4.0 ACCOUNTABILITY Production executive. 5.0 PROCEDURE 5.1 Avoid wrong entries in BMR/BPR. 5.2 Make corrections if necessary by putting a straight line across the wrong entry. So that it is clearly visible . 5.3 Write the correct figure/text near the wrong entry. 5.4 Put your signature or initial along with date near the correction.

1.0 OBJECTIVE To lay down a procedure for leak testing of strips / blisters. 2.0 SCOPE All packing areas. 3.0 RESPONSIBILITY Production officer. 4.0 ACCOUNTABILITY Production executive 5.0 PROCEDURE 5.1 Take the required number of strips / blisters as mentioned in the Annexure – I. Check the quality of strips/ blisters for any damages. 5.2 Tie the collected strips / blisters with a rubber band. 5.3 Ensure that all strips / blisters are dipped in water and close the lid. 5.4 Connect opening of the desiccator to the vacuum pump. 5.5 Apply a vacuum of 300 mm of Hg and close the knob of the desiccator. 5.6 Keep the vacuum for 30sec. 5.7 Release the vacuum by opening the knob of the desiccator slowly and open the lid remove the strips / blisters. 5.8 Wipe out the traces of water from the strips / blisters by using lint free duster . 5.9 Open the pocket of strips by using scissors to remove the tablets / capsules. 5.10 Open the blisters manually. 5.11 Check for any traces of water inside the...

1.0 OBJECTIVE To lay down a procedure for recording and monitoring of differential air pressure. 2.0 SCOPE All Modules, Dispensing cubicles, & Primary packing areas. 3.0 RESPONSIBILITY Concerned officer. 4.0 ACCOUNTABILITY Concerned executive 5.0 PROCEDURE 5.1 Record the differential pressure between outer corridor and gowning rooms twice daily (Locations of manometers given in Annexure-I ). 5.1.1 Pressure differential limit is 1.0 -1.6mm of water guage. 5.2 Record the differential pressure between Inner corridor and process rooms twice daily (Locations of manometers given in Annexure-I ). 5.2.1 Pressure differential limit is 0.6 -1.0 mm of water guage. 5.3 If any discrepency is observed report to maintenance for corrective action. 5.4 Stop the process till the corrective action is taken. 5.5 If the material is stored in open containers, seal the containers with film / lids. 5.6 Once the corrective action is taken, record pressure differential and start the process. ANNEXURE - I LO...

1.0 OBJECTIVE To lay down a procedure for defoiling of blisters / strips. 2.0 SCOPE All primary packing halls. 3.0 RESPONSIBILITY Concerned operator. 4.0 ACCOUNTABILITY Production officer. 5.0 PROCEDURE 5.1 Use clean gloves during defoiling of strips / blisters. 5.2 Cut, rejected strips by using scissors without damaging tablets / capsules over polythene bag lined SS Trays . 5.3 Remove tablets / capsules by hand from cut strips/blisters. 5.4 Sort out good tablets by removing foil pieces and broken tablets / damaged capsules. 5.5 Collect tablets with black particles, oil stains and put them in a bag labelled as “TO BE DESTROYED “. 5.6 Put all Recoverable tablets / capsules in a new polythene bag, properly labelled and tied with nylon thread, and keep in a HDPE container. Put the RR’s label on the container. 5.7 Get the quantity of sorted tablets checked by two production officers or by Quality Assurance officer . 5.8 Pack separately such defoil...

1.0 OBJECTIVE To lay down a procedure for handling of finished goods. 2.0 SCOPE All packing halls. 3.0 RESPONSIBILITY Production officer. 4.0 ACCOUNTABILITY Production executive 5.0 PROCEDURE 5.1 Raise production transfer slip and get it cleared timings. 5.2 Send approved shippers on a pallet to bond room on hydraulic trolley. 5.3 Check the number of shippers physically to be transferred to bonded storage area and tally the same with details in the batch packing record, duly checked and dated.

1.0 OBJECTIVE To lay down a procedure for returning of unused raw and packing materials. 2.0 SCOPE Module 1,2,3,4,5 and packing areas. 3.0 RESPONSIBILITY Production officer / Executive. 4.0 ACCOUNTABILITY Production manager. 5.0 PROCEDURE 5.1 Returning of unused Raw materials. 5.1.1 Return unused materials along with stock return note as per format No: xxxxx 5.1.2 Ensure all unused raw materials are tied in separate poly bags with stock return labels and keep them in in-process container and send them to dispensing area along with stock return note or through system generated stock return note. 5 .2 Returning of unused packing materials. 5.2.1 Return unused packing material along with SRN as per (Annexure-I). 5.2.2 Ensure that all the packing materials are properly labelled. 5.2.3 Place them in a trolley / crates and send to stores with an authorized stock return note duly approved by production Officer. Annexure-I STOCK RETURN NOTE No: Module: Product: B.No: Date: Returned by with dat...

1.0 OBJECTIVE To lay down a procedure for destruction of rejected FBD & FEM bags. 2.0 SCOPE Module - 1,2,3 & 4. 3.0 RESPONSIBILITY Concerned Junior Technical officer / Operator. 4.0 ACCOUNTABILITY Production officer. 5.0 PROCEDURE 5.1 Wash the torn , old FBD / FEM bags with potable water jet. 5.2 Dry the washed FBD/FEM bags in FBD using steam. 5.3 Cut the torn, old FBD/FEM bags into pieces and send to house keeping department with label for disposal, with a disposal note duly authorized by Sr. Executive. 5.4 Record the same destruction details in the FBD / FEM bag control card.

1.0 OBJECTIVE To lay down a procedure for transfer of materials from dispensing to module, from module to hold area and to primary packing. 2.0 SCOPE Module - 1,2,3,4 and 5. 3.0 RESPONSIBILITY Concerned production associate / operator. 4.0 ACCOUNTABILITY Production officer 5.0 PROCEDURE 5.1 Transfer of raw materials to module 5.1.1 Ensure that all the dispensed materials are kept in labelled in-process containers (IPC). 5.1.2 Clean the IPC wheels with lint free duster before transferring. 5.1.3 Transfer the IPC to module raw material hold room with batch document. 5.2 Transfer of material from module to hold area (Quarantine). 5.2.1 Ensure that all HDPE drums are properly labelled and are clean from outside. 5.2.2 Transfer all HDPE drums containing materials in an SS trolley from module air lock to quarantine with batch document. 5.2.3 Keep drums separately lot wise and keep batch do...

1.0 OBJECTIVE To lay down a procedure for cleaning of new equipment. 2.0 SCOPE Module 1,2,3,4 & 5 and Packing areas. 3.0 RESPONSIBILITY Production officer / Executive. 4.0 ACCOUNTABILITY Sr. Executive - Production. 5.0 PROCEDURE 5.1 De-dust the equipment with vacuum cleaner / lint free duster 5.2 Clean the equipment with potable water jet (where ever applicable) using scrubber. 5.3 Clean the equipment with 0.5% teepol solution using scrubber. 5.4 Rinse the equipment with potable water jet (where ever applicable). 5.6 Use IPA / Acetone to clean the parts where ever applicable. 5.7 Finally rinse the equipment with purified water jet (where ever applicable). 5.8 Verify that cleaning is appropriate and satisfactory by visual inspection. 5.9 Get ‘CLEANED’ label signed by the production officer and fix it to the machine. 5.10 Use the equipment only after completion of IQ, OQ and PQ by validation department

1.0 OBJECTIVE To lay down a procedure for transferring of machine under major break down. 2.0 SCOPE Module -1,2,3,4 and 5. 3.0 RESPONSIBILITY Production officer. 4.0 ACCOUNTABILITY Executive / Sr. Executive. 5.0 PROCEDURE 5.1 Raise major breakdown request to maintenance through engineering helpdesk. 5.2 Transfer the machine to the respective module air lock. 5.3 Maintenance department transfers the machine from air lock to the repair bay. 5.4 Concerned production officer shall examine the machine after necessary repairs. 5.5 After getting clearance from concerned production officer, transfer the machine to the respective area. Place the caution while in operation as follows CAUTION:ENSURE NOT TO DAMAGE EPOXY FLOORING.

1.0 OBJECTIVE To lay down a procedure for maintaining inventory of sieves. 2.0 SCOPE Module - 1,2,3,4 and 5. 3.0 RESPONSIBILITY Production officer. 4.0 ACCOUNTABILITY Production executive 5.0 PROCEDURE 5.1 Check the sieves against indent for required numbers and sizes and enter the details in the sieve inventory record. 5.2 Sieves inventory to be maintained as per the details mentioned in the Annexure -I . 5.3 If any sieve observed damaged discard immediately and replace with new approved sieve and enter the details in the sieve inventory record. 5.4 Module wise sieve inventory record to be maintained by production department as per Annexure – I every month. 5.5 Sieve size should be measured by counting the no of apertures per linear inch. 5.6 All the sieves should be of ASTM/ BSS standards. ANNEXURE - I Module : Month: Date:

1.0 OBJECTIVE To lay down a procedure for maintenance of dies and punches. 2.0 SCOPE Module- 2,3 & 4 3.0 RESPONSIBILITY Production officer 4.0 ACCOUNTABILITY Production Executive 5.0 PROCEDURE 5.1 Check all the punches and dies immediately after receiving from stores, count them and record in punches and dies stock card (Annexure - I) in format No.: xxxx 5.2 Inform immediately if any damaged punches and dies are found and record the number of damaged punches and dies, in stock cards. 5.3 Send to Engineering department for defacing along with stock return note. 5.4 Keep all good upper punches, lower punches and dies and labelled the box with details of product, size, shape and number. Keep them in quarantine. 5.5 When punches and dies are required, take required number of punches and dies to the production area and make entry in stock card. 5.6 Get stock card checked & signed by production officer. 5.7 If any damage of punches and dies occurred during compression, inform immedia...

1.0 OBJECTIVE To lay down a procedure for returning of on-line rejected packing materials. 2.0 SCOPE All packing areas. 3.0 RESPONSIBILITY Production officer and Quality assurance chemist. 4.0 ACCOUNTABILITY Production executive and Quality Assurance executive. 5.0 PROCEDURE 5.1 Any packing materials are observed to be defective on - line, such as having shade variation, printing, lamination problems with foils and locking, printing problems with cartons. 5.2 Paste the on-line rejection label and keep the material aside. 5.3 Weigh the quantity / count the number to be rejected on-line. 5.4 Inform to quality assurance and get the approval for the same. 5.5 Raise the on-line rejection format as per Annexure-I in triplicate and enclose the rejected material samples and get it checked by production executive and QA executive. 5.6 Return the material to the stores by SRN as per Annexure -II. 5.7 Once again ensure the A.R.No of on-line rejected material, before returning to the stores. 5.8 I...

1.0 OBJECTIVE To lay down a procedure for startup and closing of packing line. 2.0 SCOPE All packing areas. 3.0 RESPONSIBILITY Production officer. 4.0 ACCOUNTABILITY Production executive 5.0 PROCEDURE START UP 5.1 Ensure the cleanliness of the area before starting of the operation. 5.2 Ensure that all packing materials are belonging to the respective product and batch number. 5.3 Ensure that line clearance is given by two production officers or by Q.A. 5.4 Put the equipment status label on the machine. 5.5 Switch “ON” the machine. Note down the sealing temperature and environmental conditions in batch packing record with sign and date also check the foil proof for batch details against PWO by two production officers or by QA. 5.6 Check the leak test for strips / blisters / quality of packs and give the clearance to start the belt. CLOSING: 5.7 Clear off the packing material from the belt during lunch break and at t...

1.0 OBJECTIVE To lay down a procedure for handling of new machines. 2.0 SCOPE Module-1,2,3,4,5, packing areas and stores. 3.0 RESPONSIBILITY Maintenance executive / Production executive. 4.0 ACCOUNTABILITY Maintenance manager / Manager - Production. 5.0 PROCEDURE 5.1 Maintenance executive along with the packing list shall examine the machine. 5.2 If the packing list is reconciling with the machine / parts, transfer the machine to finished goods store. 5.3 If the packing list is not reconciling with the machine / parts, maintenance executive shall generate a report and send to the supplier. 5.4 If the machine is small use battery operated pallet truck to transfer the machine into the respective area. 5.5 If the machine is big use sufficient manpower to transfer the machine into the respective area, manually. 5.6 While transferring manually use PVC sheet / Rubber mat on the floor. CAUTION: NEVER KEEP THE MACHINE DIRECTLY ON THE FLOOR. 5.7 ...

1.0 OBJECTIVE To lay down a procedure for indenting the rubber stereos to be used for over printing purpose. 2.0 SCOPE Formulation Unit xx 3.0 RESPONSIBILITY Packing Officers. 4.0 ACCOUNTABILITY Production Executives. 5.0 PROCEDURE 5.1 After receiving the production month plan from PPIC, the number of batches to be manufactured in the month will be identified by concern production executive, along with Manufacturing and Expiry details. 5.2 The above will be informed to concern production officer. 5.3 Production officer will indent the stereos accordingly for 5.3.1 Foil over printing stereos for blister / strip machine. 5.3.2 Carton over printing stereos. 5.3.3 Shipper coding stereo required if any. 5.4 The indent will be checked by Production Executive. The indent will give through Fax or E.Mail to stereo Manufacturer

1.0 OBJECTIVE To lay down a procedure for returning of on-line rejected raw material. 2.0 SCOPE Module 1,2,3,4 and 5. 3.0 RESPONSIBILITY Production officer / QA officer. 4.0 ACCOUNTABILITY Production Executive, Group leader / Quality Assurance. 5.0 PROCEDURE 5.1 If the raw materials are observed to be defective on - line, such as having lumps or foreign materials, paste the on-line rejection label and keep the materials aside. 5.2 Weigh the quantity / count the number to be rejected and check the AR Number of the materials. 5.3 Enter the details in online rejection format as per Annexure –I. 5.4 Inform to Quality assurance officer / executive and get the approval for the same. 5.5 Enter the details of materials rejected on-line in stock return note as per Annexure –II and take authorized sign by production officer / executive and Quality assurance officer / Executive. 5.6 Return the materials to stores. Annexure-I ON-LINE REJECTION FORMAT Date :____________ Location :__________ Name of...

1.0 OBJECTIVE To lay down a procedure for disposal of material. 2.0 SCOPE Module - 1,2,3,4,5 and packing areas. 3.0 RESPONSIBILITY Production officer / House keeping officer. 4.0 ACCOUNTABILITY Production executive 5.0 PROCEDURE 5.1 Used stereos: 5.1.1 Cut the stereos into pieces after each campaign and hand over to House keeping department for disposal with proper label. 5.2 Left-over overprinted cartons / labels after batch completion: 5.2.1 Send all used / Unused discarded cartons / Labels having Company's logo for shredding to house keeping department for disposal. 5.3 Empty strips / blisters and defoiled strips / blisters: 5.3.1 Collect all empty strips / defoiled strips / blisters at the end of the shift / end of the batch, weigh and record the weight in the batch packing record. 5.3.2 Send the same to the house keeping department for shredding and disposal with proper labelling. 5.4 Used polythene bags:...

1.0 OBJECTIVE To lay down a procedure for exit from, 1) Secondary packing halls. 2) Secondary packing material store. 3) Finished goods stores. 2.0 SCOPE Applicable to all the personnel who are leaving the areas mentioned in objective. 3.0 RESPONSIBILITY Concerned person. 4.0 ACCOUNTABILITY Workmen(T)/Production Associates/Technical Associates/ Jr. Technical Officers-Production officer Officers-Executive Executive and above-Plant Manager 5.0 PROCEDURE 5.1.0 Precautions 5.2.0 Exit procedure. 5.1.0 Precautions 5.1.1 Keep the slippers in the rack in orderly manner. 5.1.2 Every alternative day / Product change over / Whenever necessary put the dress in the bin marked as uniform for cleaning. 5.1.3 Do not dump the removed uniform in the locker, which is to be used next day. 5.1.4 Fold the dress gently and keep it in the locker. 5.1.5 Do not cross the bench with the primary dress. 5.1.6 Entry of gents into ladies change rooms or vice-v...

1.0 OBJECTIVE To lay down a procedure for primary changing before personnel entering into, 1) Secondary packing halls. 2) Secondary packing material ware house 3) Finished goods ware house. 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 Workmen(T) /Production Associates/Technical Associates/ Jr. Technical Officers-Production officer. Officers-Executive. Executive and above-Plant Manager. 5.0 PROCEDURE 5.1.0 Precautions. 5.2.0 Entry procedure. 5.1.0 Precautions 5.1.1 There is a separate entry available for Ladies and Gents. 5.1.2 Entry of Gents into Ladies change rooms or vice-versa is strictly prohibited. 5.1.3 Ensure the air curtains and insecticutors are working (in all working shifts). 5.1.4 If not working inform maintenance for rectification. 5.1.5 Any authorized person wishes to enter into pharma Secondary packing areas...

1.0 OBJECTIVE To lay down a procedure for cleaning of production aids. 2.0 SCOPE Module - 1,2,3,4 and 5 Process Applicable to S.S.scoops, S.S.spatullas, beakers, S.S containers SS bowls, flexible hoses and silicon tubes. 3.0 RESPONSIBILITY Concerned operator. 4.0 ACCOUNTABILITY Production officer. 5.0 PROCEDURE 5.1 Clean with potable water jet and lint free duster to remove adhering material. 5.2 Use purified water and nylon brush to clean them. 5.3 Rinse with purified water. 5.4 Dry with lint free duster.

1.0 OBJECTIVE To lay down a procedure for maintaining environmental conditions. 2.0 SCOPE Module - 1,2,3,4,5,6 , Quarantine, primary packing rooms and secondary packing areas. 3.0 RESPONSIBILTY Concerned operator. 4.0 ACCOUNTABILITY Production Officer / Executive. 5.0 PROCEDURE 5.1 Record the environmental condition two times in a day. 5.2 Preferably take one reading in the morning and one reading in the afternoon. 5.3 If the conditions are more than the R&D specified limits / B.M.R, stop the operation and intimate to maintenance department for necessary rectification. 5.4 Start the operations only after attaining the required conditions and make the record of the same.

1.0 OBJECTIVE To lay down an exit procedure before the personnel leaving from A) Pharma manufacturing modules. B) Dispensing rooms. C) Primary packaging machine rooms. D) Raw material sampling room. 2.0 SCOPE Applicable to all persons who are leaving the above mentioned areas. 3.0 RESPONSIBILITY Concerned persons. 4.0 ACCOUNTABILITY Workmen(T) /Production associates/Technical associates/ Jr. Technical officers-Production officer Officers-Executive Executive and above-Plant manager. 5.0 PROCEDURE 5.1.0 Precautions. 5.2.0 Exit procedure. 5.1.0 Precautions. 5.1.1 The soiled gowns (boiler suits) to be washed are to be put in separate bin Identified for that purpose. 5.1.2 Hang your gown (boiler suit) to the hanger. 5.2.0 Exit procedure 5.2.1 Enter the gowning room through process corridor of the module. 5.2.2 Remove the gloves and put them in SS box labelled as ‘used gloves’. 5.2.3 Remove the headgear and hang i...

1.0 OBJECTIVE To lay down a procedure before the personnel entering into: A) Pharma manufacturing modules. B) Dispensing rooms. C) Primary packing machine rooms. D) Raw material sampling room. 2.0 SCOPE 2.1.1 Applicable to all persons who are entering in to the above mentioned areas. 3.0 RESPONSIBILITY Concerned persons. 4.0 ACCOUNTABILITY Workmen(T) /Production associates/Technical associates/ Jr. Technical officers-Production officer Officers-Executive Executive and above-Plant Manager 5.0 PROCEDURE 5.1.0 Precautions. 5.2.0 Entry procedure. 5.1.0 Precautions 5.1.1 The person allotted to one module or work place should not enter into the other Modules or work place without proper reason or until and unless authorized by the concerned department heads. 5.1.2 Every alternative day / product changeover or whenever necessary the boiler suit should be changed. 5.2.0 Entry procedure 5.2.1 Enter respective gowning rooms through external corridors (through personne...

1.0 OBJECTIVE To lay down a procedure for exit from a) Pharma production. b) Ware house (raw and primary packing materials). c) Primary packing. 2.0 SCOPE Applicable to all the personnel who are leaving the areas mentioned in objective. 3.0 RESPONSIBILITY Concerned person. 4.0 ACCOUNTABILITY Workmen(T) /Production associates/Technical associates/ Jr. Technical officers -Production officer Officers-Executive Executive and above - Plant Manager 5.0 PROCEDURE 5.1.0 Precautions. 5.2.0 Exit procedure. 5.1.0 Precautions 5.1.1 Keep the slippers in the rack in orderly manner. 5.1.2 Every alternative day / product change over / whenever necessary put the dress in the bin marked as uniform for cleaning. 5.1.3 Do not dump the removed uniform in the locker, which is to be used next day. 5.1.4 Fold the dress gently and keep it in the locker. 5.1.5 Do not cross the bench with the primary dress. 5.1.6 Entry of ...

1.0 AIM: The basic aim behind this exercise is to provide Terminal HEPA Filters for the Compression Area, with Overhead Feeding Room & Airlock and provide temperature and humidity control so that the product passing through shall remain under the same conditions as that of manufacturing areas. Based on the actual observations of the present operating system it was decided to form the System Design Basis on following assumptions: 1.1 To provide Terminal HEPA filters in the Supply air path so as to achieve most effective Air Filtration System within the given limitations. 1.2 The air changes will be kept as minimum 25 air changes per hour. 1.3 Pressure Gradient shall be maintained from Passage to Compression Area to prevent cross contamination and to prevent ingress of untreated external air. 1.4 Heating Coil with Hot water shall be provided to maintain the required Relative Humidity. 1.5 The return air risers shall be provided with Grilles for pick up of room Air. 1.6 The motor of A...

Purpose : To provide the documentary evidences that the HVAC system of System No. even numbered... · Designed as per XXXX requirement · Installed as per design specification · Operating as per set parameters and · Performing as per its intended use. Scope: This qualification protocol is applicable to the HVAC system of XXX Drug Area designed by M/s. (Contracting company) and installed by them. Intended Use : · To supply the required air quantity to the Compression Room to provide product protection from air borne contamination. · To maintain the temperature and humidity for process as required by the product specification. · To provide room pressure gradient to prevent ingress of contaminant Location : Service floor, XXXX, (Place). Reference : NA Attachments : Ducting Layout As Attachment (User Should attach one layout) G.A. Drawing for Air Handling Unit As Attachment (User Should attach one layout) Air Flow Diagram As Attachm...

1.0 PURPOSE : To provide proper guidelines for painting. 2.0 SCOPE: Whole plant. 3.0 RESPONSIBILITY: Maintenance department. 4.0 ACCOUNTABILITY: Head of Maintenance department. 5.0 DEFINITIONS: Nil. 6.0 PROCEDURE: 6.1 GENERAL: 6.1.1 In manufacturing, filling, coating, sampling, dispensing areas and corridor, air lock the flooring is epoxy. Concrete pillars and beams are painted with PU Paint. All other areas (Store, Packing hall, Corridors) wall and ceiling is painted with Acrylic Emulsion paint. All utility areas and structure are painted with synthetic enamel paints. 6.2 FOR PU PAINTING: 6.2.1 The area is properly leveled with terraco plaster. On the prepared surface poly urethane primer is applied with brush. The surface is dried for 3 to 4 hours. When surface is tacky the first coat of PU paint is applied with brush. Three such coats are applied. Each coat is allowed to dry for 8 to 10 hours. 6.3 FOR EPOXY FLOORING: 6.3.1 The flooring is properly cleaned with wire brush to remove a...

1.0. PURPOSE: To provide a procedure for operating dissolution test apparatus. 2.0. SCOPE: This covers the procedure for operating dissolution test apparatus MAKE : ELECTROLAB MODEL : TDT-08 L 3.0. RESPONSIBILITY: 3.1. Officer-Quality Control 3.2. Executive-Quality Control 4.0. ACCOUNTABILITY: Manager-Quality Control 5.0. DEFINITION: Nil 6.0. PROCEDURE: 6.1. Ensure the calibration status is valid and make sure that the instrument is properly placed for use. 6.2. Fill the distilled water in the tank up to the mark level without jars. Place the tank on the base of the instrument such that four screws at the bottom of the tank fits in to the holes on the base plate and heater cable is at the rear side of the instrument. 6.3. Connect the heater plug in the socket provided at the right hand side of the stirrer unit, fill the tank with water up to the level marked without placing any jar in the bath .Add 0.01%cetyl puridinium chloride or sodium benzoate or Bronidiol to prevent fungal grow...

1.0 PURPOSE : To provide a procedure for calibrating Disintegration tester. 2.0 SCOPE : This covers the procedure for calibrating Disintegration tester ( QCI – 21 ). MAKE & MODEL : Electrolab, ED-2L (USP). 3.0 RESPONSIBILITY : QC officer. 4.0 PROCEDURE : 4.1 TEMPERATURE CHECK : 4.1.1 Keep about 800 ml of water in 1 liter beaker in the water bath. 4.1.2 Set the temperature to 37°C. 4.1.3 Wait until the set temperature reaches. 4.1.4 Observe and record the temperature, Acceptance limit : 37°C ± 0.5°C. 4.2 STROKE HEIGHT: 4.2.1 Measure the distance between lowest and highest stroke, Acceptance limit : 53mm to 57 mm. 4.3 CYCLES 4.3.1 Count the number of cycles per minute, Acceptance limit : 28 – 32 cycles/minute. 5.0 FREQUENCY OF CALIBRATION : Once in a month.

1.0. PURPOSE: To provide a procedure for operation of Disintegration tester. 2.0. SCOPE: Applicable to Disintegration tester MAKE & MODEL : Electrolab, ED-2AL 3.0. RESPONSIBILITY: 3.1. Officer-Quality Control 3.2. Executive-Quality Control 4.0. ACCOUNTABILITY: Manager-Quality Control 5.0. DEFINITION: Nil 6.0. PROCEDURE: 6.1. Ensure the calibration status is valid and make sure that the instrument is clean and free from dust. 6.2. Switch on the main switch and put on the ‘ON/OFF’ switch at the rear panel to ‘ ON’ position Follow the procedure to set the temperature. 6.3. For setting the temperature select the BATH probe by pressing PROBE key. This key toggles between BATH probe EXTSEL a) Press SET key – LED to the right of the key will glow. b) Press TEMP key- Temperature display shows previous set temperature with right most digit flashing. c) Press ▲ key –Flashing digit value will show increment for every key press. OR d) Press ▼ key - Flashing dig...

1.0. PURPOSE: To provide a procedure for operating the UV – VIS Spectrophotometer. 2.0. SCOPE: This covers the procedure for operating UV–VIS Spectrophotometer. MODEL : UV-1700 with PC software MAKE : Shimadzu. 3.0. RESPONSIBILITY: 3.1. QC-Chemist 3.2. QC-Officer 4.0. ACCOUNTABILITY: Manager-Quality Control 5.0. DEFINITION: Nil 6.0. PROCEDURE: 6.1. For PHOTOMETRIC 6.1.1. Switch on the instrument and computer 6.1.2. Check the connection cable to the PC is properly connected or not. 6.1.3. Select the icon of UV probe and click double 6.1.4. Press PC control (F4) in the instrument. 6.1.5. Select the icon Photometry. 6.1.6. Click the CONNECT icon. 6.1.7. Place the blank solution in sample compartment 6.1.8. Click the method icon(M).The page will be opened enter the wavelength & add the parameter, select calibration and enter raw data and close the window and method should be saved in method folder( which is suitable for name of the sample). 6.1.9. Keep blank and perform AUTOZERO 6...

1.0. PURPOSE: To provide procedure for Operation of High Pressure Liquid Chromatography. 2.0. SCOPE: Applicable to HPLC (CodeNo. ) : Make : Shimadzu Model : LC-2010A Pump : LC-10Atvp Detector : SPD-10Avp System Controller : SCL-10Avp Auto Injector : SIL-10Advp 3.0. RESPONSIBILITY: 3.1. QC- officer 3.2. QC- Executive 4.0. ACCOUNTABILITY: Manager-Quality Control 5.0. DEFINITION: Nil 6.0. PROCEDURE: 6.1.1. Check and ensure that the instrument is clean and calibration is valid. 6.1.2. Switch on SCL10Avp system control,SPD 10Avp UV-Visible detector, followed bySQL/10ADvp autoinjector & followed by LC10ATvp pump. 6.1.3. Then start the computer (Softwere),wait for a while;Till enter Password, appear on the monitor. 6.1.4. Enter the passw...

1.0 PURPOSE : To provide a procedure for Calibration of Gas Chromatography 2.0 SCOPE: This covers the procedure for operating Gas Chromatography MAKE: Shimadzu, MODEL : GC-2010. 3.0 RESPONSIBILITY: 3.1. Officer-QC 3.2. Executive-QC 4.0. ACCOUNTABILITY: Manager-Quality Control 5.0. DEFINITION: Nil 6.0. PROCEDURE: 6.1. SYSTEM SUITABILITY Run for every analysis in replicate 4 at the beginning and 2 at the end. Calculate RSD for retention time. 6.2. COLUMN AND INJECTION PORT 6.2.1. Inject 1ml of mixture of methanol and toluene (1:10) at the following conditions. a. Mobile phase : Nitrogen gas, b. Injector port temperature : 150°C, c. Detector temperature : 150°C FID, d. Column temperature : 120°C. Inject in replicate and calculate the RSD for retention time. Limit : NMT 2.0 Incase of abnormality. a. Change the septum, b. Clean the injection port d. Purge the nitrogen gas through column for 2 hours 6.3. FREQUENCY OF CALIBRATION: Once in 3 months 7.0. REFERENCES: Nil 8.0. ENCLOSURES: Report ...

1.0 PROCEDURE : 1.1 Clean the drier, the air filters and exhaust system thoroughly, 1.2 Ensure that the air dampers are kept open fully, 1.3 Ensure that the dial gauge is clean, 1.4 The probes of inlet thermometer and outlet thermometers of the fluid bed drier are kept in oil bath along with standard thermometer and heated to note down the readings at various temperatures. 1.5 Record the temperature shown on the dial thermometer of the drier at an interval of 10 degree centigrade and corresponding temperature on the standard thermometer, 1.6 Calculate the percentage variation and check with the limits, 2.0 DOCUMENTATION : 2.1 F:Sxxxx/FBR - Fluid bed drier Temperature Guage Calibration Record.

1.purpose : Cleaning, Calibration and operational procedure of 6- Station Dissolution Apparatus. 2.Scope : This procedure is applicable to clean, calibrate and operate 6- Station Dissolution Apparatus. Instrument:Dissolution Apparatus Make: Electrolab 3.Reference / Attachments : 3.1 Reference 3.1.1 None 3.2 Attachments 3.2.1 Attachment – I : Instrument Usage Log Attachment – II : Calibration Label Attachment – III : Monthly calibration log for pH meter Attachment – IV : History Card Attachment – V : periodic Cleaning 4.Responsibility 4.1 Quality Head location 4.1.1 To review, audit and approval of SOP 4.1.2 Implementation of system as per SOP. 4.1.3 Training to the concern before implementation of SOP. 4.1.4 To ensure the operation, calibration and maintenance of the instrument is as per recommended Procedure. 4.2 Head Quality control 4.2.1 To ensure proper documentation as per SOP 4.2.2 To initiate the maintenance activ...

1.0 PROCEDURE : 1.1 Clean the drier, the air filters and exhaust system thoroughly. 1.2 Ensure that the air dampers are kept open fully, 1.3 Ensure that the probe of the dial guage is clean. 1.4 Start the drier and keep a standard thermometer of 110°C range near the probe. 1.5 Check the temperature shown on the dial thermometer on the drier at an interval of 10 degree centigrade and the corresponding temperature on the standard thermometer. 1.6 Record and calculate the percentage variation and check with the limits. 2.0 DOCUMENTATION : 2.1 F:Sxxxx/DTR - Drier Temperature Guage Calibration Record.

1.0 PROCEDURE 1.1 Place the standard dry wet bulb thermometer in the area along with the dry wet bulb thermometer used is to be calibrated. 1.2 Record the wet and dry bulb temperature of the thermometers at various intervals during the course of the day (at least five readings) 1.3 Calculate the percentage relative humidity by taking the difference of dry and wet bulb thermometers by referring to table of wet and dry bulb thermometer readings with corresponding percentages of humidity as read in the standard hygrometer. 1.4 Calculate the percentage variation and check with limits, 1.5 Reference table attached, Limits : Relative humidity 50 ± 2% 2.0 DOCUMENTATION : F:Sxxxx/WBR - Dry and Wet bulb Calibration Record.

1.0 PROCEDURE 1.1 PREPARATION OF STANDARD STOCK SOLUTIONS 1.1.1 Potassium chloride stock solution Weigh accurately 0.75 g of KCl to a 1000 ml volumetric flask, shake well, to dissolve and make up the volume with the distilled water. 1.1.2 Sodium chloride stock solution Weigh accurately 1.170 g of sodium chloride to a 1000ml volumetric flask, shake well to dissolve and make up the volume with the distilled water. For calibration dilute the above stock solution as follows

1.0 PROCEDURE : 1.1 PREPARATION OF STANDARD STOCK SOLUTION OF QUININE SULFATE: Weigh accurately 10mg of Quinine sulfate and dissolve in 0.1N Sulfuric acid and make up to volume with 0.1N Sulfuric acid to 1000mL. Preserve this solution, protected from light, in a refrigerator. For calibration, dilute the above stock solution as follows: Soln. 1.5ml - 200ml with 0.1 N Sulfuric acid (0.25 mcg/ml) Soln. 2.4ml - 200ml with 0.1 N Sulfuric acid (0.20 mcg/ml) Soln. 3.3ml - 200ml with 0.1 N Sulfuric acid (0.15 mcg/ml) Soln. 4.2ml - 200ml with 0.1 N Sulfuric acid (0.10 mcg/ml) Soln. 5.1ml - 200ml with 0.1 N Sulfuric acid (0.05 mcg/ml) 1) Select the instrument as per the Operating Procedure. 2) Select Primary filter (366 nm) and Secondary filter (4308 nm) 3) Adjust the blank to zero with 0.1 N Sulfuric acid. 4) Place the diluted solution 1 in the cuvette. Adjust the reading to 100 and place the other diluted solutions in the cuvette and note down the readings.

1.0 PROCEDURE 1.1 CALIBRATION OF PUMP : Start the HPLC pump as per IOP and check the flow rate by collecting water in a 10ml measuring cylinder. Using a stop watch set the time for 5 minutes and measure the volume collected for 1.0ml/ minute 1.5/minute and 2.0ml/minute flow rates respectively. Note the readings in duplicates. 1.2 CALIBRATION OF DETECTOR To a clean, dry 100ml volumetric flask, add 0.1ml of Benzene and 0.1ml of Toluene. Mix by adding mobile phase and make up to volume. Inject equal quantities three times and record the ratio of the peak area. Chromatographic conditions Detector : 254nm Flow Rate : 1.0 ml/minute Mobile Phase : Methanol : Water = 80 : 20 Absorbance Scale : 0.02 Attenuation : 5 Injection Volume : 20micro litre Column : C-18 (Shim-pak) Area of first peak Calculation : = Ratio Area of second peak 2.0 DOCUMENTATION 2.1 F:Sxxxx/HCR - HPLC Calibration Record.

1.0 PROCEDURE: Spectrophotometers for recording spectra in the infra red region consists of an optical system capable of providing monochromatic light in the region of 4000 to 670 cm-1 (about 2.5 to 15mm) or in some cases down to 200cm-1 (50mm) and a means of measuring the Quotient of the intensities of the transmitted light and the incident light. 1.1 Resolution Performances of the Apparatus: The instrument used for recording infrared spectra should comply with the following test for resolution. Record the spectrum of the polystyrene film 0.05mm thick. The depth of the through from the maximum absorption at 2851 cm-1 (3.51mm) to the minimum at 2870 cm-1 (3.48mm) should be greater than 18% transmittance and that from the maximum at 1583 cm-1 (6.23mm) to the minimum at 1589 cm-1 (6.29mm) should be greater than 12% transmittance. Verification of the wave-number scale The wave number scale may be verified using a polystyrene film which has maxima at the wave-number (in cm-1) 8 hours. The...

1.0 SETTING OF TANK : 1.1 Clean the tank throughly using water. 1.2 Place the tank in a particular place and level it using a spirit level. 1.3 Mark the position of the wheel on all the four sides. 2.0 STANDARDISATION OF WATER : 2.1 Take a clean 20-L stainless steel (S.S) Vessel. 2.2 Weigh and note down the empty weight (B) 2.3 Add about 15-L water and note down the total weight (A). Check temperature (T degree C). 2.4 Note down the weight of water (C) Taken by subtracting B from A. 2.5 Calculate the specific gravity of water, 2.6 Calculate the quantity of water in terms of Liter equivalent to the weight taken using the following formula. Volume of water in Liters = Weight of water (C) in kg / Specific gravity of water at temp T°C

1.0 PURPOSE : To provide a procedure for periodic calibration of pH meter. 2.0 SCOPE : Covers procedure for the calibration of pH meter (daily and monthly) and also for the activation of electrode and maintenance of electrode. 3.0 DEFINITION : 3.0.1 pH: pH value conventionally represents the acidity or alkalinity of an aqueous solution. 3.0.2 CALIBRATION : The set of operations which establish, under specified conditions, the relationship between values indicated by a measuring instrument or measuring system or values represented by a material measure and the corresponding known values of a reference standard. 4.0 PROCEDURE : 4.1 PREPARATION OF BUFFER SOLUTION Buffer solution D: (pH 4.01) Dissolve 10.21 g of potassium hydrogen phthalate, previously dried at 110 degree to 130 degree for 2 hours in sufficient carbondioxide free water to produce 1000mL. Buffer solution E: (pH 6.87) Dissolve 3.40 g of potassium dihydrogen phosphate and 3.55 gram of anhydrous disodium hydrogen phosphate pre...