cGMP and Regulatory Updates

1.0 PROTOCOLS OF TEST 1 Description : Metalic Tins having smooth inner surface. The upper surface is sealed consists a clip to break the seal. The lower surface is open. 2 Dimensions : This test includes a) Length : This test is not applicable for Metallic Tins b) Breadth : This test is not applicable for Metallic Tins. c) Height : Measure the height in mm of 10 Metallic Tins individually from the lower surface edge to the upper rim. Note it in the report sheet. ( Limits : It should meet as per the specimen Metallic. Tins with tolerance of 170 mm ± 10 mm ) 3 Average This test is not applicable for Weight : Metallic Tins. 4 Thickness : This test is not applicable for Metallic Tins. 5 Inner : Measure the inner diameter of 10 Diameter Metallic Tins individually from the lower open edge. It should be not less than 98 mm. Note it in the report sheet. 6 Outer : Measure the outer diameter of 10 Diameter Metallic Tins individually. It should be not more than 105 mm. Note it in the...

1.0 OBJECTIVE To provide format & guidelines for individuals who participate in the implementation of standard operating procedure for cleaning of change room. 2.0 SCOPE To provide the policy & guidelines for Change room. 3.0 RESPONSIBILITY Sweeper & House keeping officer. 4.0 PROCEDURE 1. Undertake broom cleaning of change room. 2. Take 2.5% Dettol or Savlon or Phenyl soln. & undertake wet cleaning of floor with the help of Industrial cleaner or wet cloth. Daily two times a day 3. Undertake cleaning of Tablets, Benches, Basin, Cooler, Fan, Exhaust with the help of duster followed by wet cleaning with 2.5 % Dettol or Savlon soln. 4. Collect all waste of Change room in a dust bin.

1.0 PURPOSE This SOP describes the cleaning operation of centrifuge to ensure that the centrifuge is free from previous batch material. 2.0 RESPONSIBILITY Operators and chargers are responsible for the cleaning of centrifuge. 3.0 PROCEDURE a) Open the top cover of the centrifuge. b) Wash nozzles and top of the centrifuge. c) Remove centrifuge bag. d) Wash the basket with DM water and start spinning the centrifuge and under these conditions wash the basket with DM water. e) Stop the centrifuge. f) Wash the bag with DM water. g) Fix the bag in the centrifuge. h) Start the centrifuge and again wash the bag in slow speed of the centrifuge. i) Put back the cover and clamp it. 4.0 PERIODICITY Cleaning should be done after every batch. 5.0 FORMAT Equipment cleaning record format should be used.

1.0 PURPOSE This SOP describes the cleaning operation of centrifuge filters to ensure that the filters are free from previous batch material. 2.0 RESPONSIBILITY Operators are responsible for the cleaning of filters 3.0 PROCEDURE a) Dismantle the filter. b) Remove the filter element and discard. c) Clean the filter bowl with DM water and dry. d) Introduce fresh filter element. e) Assemble and fix back in position. 4.0 PERIODICITY Replacement of filter weekly. 5.0 FORMAT Equipment cleaning format should be used for recording the cleaning operations.

1.0 PURPOSE This SOP describes the cleaning operation of blender to ensure that the blender is free from previous batch material. 2.0 RESPONSIBILITY Operators and chargers are responsible for the cleaning of blender. 3.0 GENERAL CONDITIONS Disconnect all the connections of blender and open top cover .During blender cleaning all the other operations around blender should be stopped. 4.0 PROCEDURE 4.1 BATCH CLEANING OPERATION:- a) Disconnect the blender from power supply. b) Open the top cover of the blender. c) Clean the inner surface of the blender using dry mop and collect the material in acontainer. d) Clean the discharge valve of the blender. e) Close the top cover. 4.2 MAJOR CLEANING OPERATIONS i) Open top cover completely. ii) Clean the top cover and inner side of the blender using dry sponge iii) Clean the shaft and ribbons. iv) Clean the blender with the jet of compressed air. 4.3 PERIODICITY a) Batch cleaning operation should be done after completion of every...

1.0 CAUTION Switch off the electrical mains of the machine. A PROCEDURE FOR PRODUCT TO PRODUCT CHANGEOVER 1 Dedusting external surfaces. Use clean nylon brush and wipe with clean dry lint free duster. 2 Dismantling Remove a) Back and front cover. b) Empty capsules hopper. c) Magazine followed by pusher plate and raceway. 3 Cleaning of parts Clean the above parts by washing with 0.1% Teepol solution and scrubbing with soft nylon brush. Rinse with jet of potable water followed by rinsing with 5 micron filtered water. Clean loading platform with wet duster. Clean back and empty capsules hoppers using clean dry lint free duster. 4 Drying The cleaned parts as mentioned in step ( 3 ) are wiped and dried using clean dry lint free duster. 5 Assembling Reassemble all the parts of the machine carefully checking the correctness of assembling. NOTE a) Fix the ‘cleaned’ label. b) If the cleaned loader is not used within 24 hours after cleaning or there are signs of dust or powder ...

1.0 AIM To lay down a standard operating procedure for Alkali preparation tank ( for D. M. WATER PLANT). 2.0 SCOPE Maintenance Department 3.0 AREA OF OPERATION Demineralised Water Plant. 4.0 RESPONSIBILITY Operator/Maintenance Supervisor concerned. 5.0 ACCOUNTABILITY Maintenance Incharge. 6.0 PROCEDURE 6.1 Rinse the inside surface twice with D. M. Water. 6.2 Clean the inside and outside surface with 0.1% Extran or 0.1% Teepol solution. 6.3 Rinse the inside surface twice with D. M. Water. 6.4 Wipe the outside surface with duster. 6.5 FREQUENCY AFTER USE. 6.6 RECLEANING FREQUENCY Clean the tank after seven days if not used. 7.0 REVIEW DATE After 2 years or when procedure is changed.

1.0 AIM To provide standard operating procedure for cleaning and sanitation of dust bins. 2.0 SCOPE Production Department. 3.0 AREA OF OPERATION Leak Testing Area. 4.0 RESPONSIBILITY House Keeper/Production Supervisor. 5.0 ACCOUNTABILITY Production Executive. 6.0 PROCEDURE 6.1 WEEKLY CLEANING: a) Remove polybags containing scrap material from all dust bins for destruction. b) Collect all dustbins for cleaning. c) Wash dustbins by using tap water. d) Then clean it by using soap solution & scrubber. e) Then again wash it by tap water. f) Then wipe it by using clean dry clothes. g) Check for suarity of cleanliness. h) Take it for use. 6.2 DAILY CLEANING Wipe dust bin by using clean dry clothes from outside. 7.0 REVIEW DATE After 2 years or when procedure is changed.

1.0 OBJECTIVE To lay down the Standard Operating Procedure for cleaning and maintenance of the Millipore Filtration Unit. 2.0 SCOPE The procedure is applicable to cleaning and maintenance of the Millipore Filtration Unit. 3.0 RESPONSIBILITY Laboratory Technician, Scientific Assistant, Assistant Scientific Officer and Officer In charge of the Section. 4.0 PROCEDURE 1. The assembly should be checked every day for the leakage and the filters of the Swinny Filter holder ( 13 mm Millipore Filtration Unit ) before giving for sterilization. 2 The cups and the funnels also the stainless steel manifold must be washed and rinsed with the distilled water . 3 In case of leakage the O rings are to be changed 4 Once in two months clean the sintered funnels with chromic acid keeping them for over night. All the O rings are to be changed. 5 The sintered Funnels are to be cleaned thoroughly in distilled water after chromic acid treatment before assembling. The rubber parts if they are defor...

1.0 PURPOSE This SOP describes Housekeeping and cleaning procedures for stores department. 2.0 RESPONSIBILITY Stores In-charge will be responsible for monitoring housekeeping and claening of stores department. 3.0 PROCEDURE a) Arrange for cleaning of the area as per schedule. b) Arrange for regular cleaning of the bags and containers. c) The containers brought in the stores shall be free from dust. d) All the containers are checked for any leakage and original labels. e) Detailed sanitation program for stores is given below. 4.0 Daily – Cleaning and mopping of Floor, Drums and Racks cleaning. 5.0 Weekly - Doors and windows cleaning.

1.0 OBJECTIVE To lay down the Standard Operating Procedure for Cleaning Procedure for Microbiology Lab Sterile Area. 2.0 SCOPE The procedure is applicable to Cleaning Procedure for Microbiology Lab Sterile Area. 3.0 RESPONSIBILITY Laboratory Technician, Scientific Assistant, Assistant Scientific Officer and Officer In charge of the Section. 4.0 PROCEDURE 1 Daily at the start of the shift and after every work, clean the table of laminar airflow using clean mop soaked in 70% Isopropyl Alcohol. 1) Disinfect floor with either of the solutions alternately using the same mop after every work. a) 2.5% v/v Dettol b) 2.0% v/v Fairgenol c) 2.5% v/v Savlon 2) Spray the area including floor and walls with 5% v/v phenol or 2% v/v Bacillocid. 3) At every weekend clean the walls, and floor using soap solution. Wash down with plenty of water. Remove excess of water using clean mop. 4) At every week end fumigate sterile area with formalin through A/C.

1 Before dismantling the equipment the electric supply must be turned off. 2. The strap retaining the filter bag unit is unclipped and the finger sleeves of the bag are detached from the holding hooks. 3. The bag is removed and taken to the washing area where the external surface of the bag is washed with hot water. The bag is turned inside-out and then washed with hot 1 water. Where material is adhering to the bags it will be necessary to scrub the surface with a detergent solution (such as Teepol) using a nylon brush. 4. After washing, the bag is placed on a hanger and allowed to dry in air. 5. The bag support frame as well as the sleeve supports are washed with hot water and the washed surfaces are then wiped with a clean, dry cloth. 6. The drier bowl should preferably be washed after every drying cycle although if the same product is being dried in lots it will be sufficient to wash at the end of the working shift. The bowl is wheeled to the washing area where it is freed from...

1.0 PURPOSE This SOP describes the cleaning operation of sifter to ensure that the sifter is free from previous batch material. 2.0 RESPONSIBILITY Operators are responsible for the cleaning of sifter. 3.0 PROCEDURE 4.0 BATCH CLEANING OPERATION Ensure isolation of the equipment electrically. a) Remove hood from the top. b) Remove the material stuck to the sieve top. c) Clean the surface of top cover ,sifter sieve and the discharge cone with dry sponge. d) Vacuum clean all the parts of the sifter. e) Put the top cover. 4.1 MAJOR CLEANING OPERATIONS i) Repeat all the operations of batch cleaning. ii) Remove the sieve from the sifter and clean the cone and sieve joint area. iii) Reassemble the sifter and proceed for operation. 5.0 PERIODICITY a) Batch cleaning operation should be done after completion of every batch. b) Major cleaning operation once in a month. 6.0 FORMAT Equipment format should be used for recording the cleaning operations.

  1.0          PURPOSE This SOP describes the cleaning schedule for QC Department   2.0               RESPONSIBILITY Administration department is responsible for cleaning activities of the QC Department. QC Head should ensure that the cleaning activities are done as per schedule   3.0       PROCEDURE a)       Floor                     :         Clean Twice a day b)       Windows/ Walls     :         Clean Once in week c)       Ceiling                  :    ...

1.0 PURPOSE This SOP describes the cleaning operation of reaction vessel to ensure that the vessel is free from previous batch material 2.0 RESPONSIBILITY Operators and chargers are responsible for the cleaning of the reactor from the inner side. External cleaning is a continuous routine process. 3.0 PROCEDURE a) Ensure that previous batch material is completely removed from the reactor. b) Open manhole cover and close the bottom discharge valve. c) Flush the reactor with water using spray nozzle .also wash the top dish with the help of spay nozzle. d) Open bottom dish valve and drain the spray washings into the affluent tray . e) Close the bottom valve ,fill the reactor with water ,stir for 10 min. and drain out the water. f) Inspect and ensure that the reactor is clean. g) If required repeat the above operations using detergents. h) When the previous material is insoluble in water ,clean the reactor with solvent in which it is soluble and then with water. i) Clean the ma...

1.0 Approval Pre approval of this protocol will be the joint responsibility of the following functional areas. Quality Assurance Production Engineering Product Development Post approval of this protocol will be the joint responsibility of the following functional areas. Quality Assurance Production Engineering Product Development 2.0 Statement of Purpose The purpose of this protocol is to provide an outline for the design of the NEW Computer System be procured. The system shall be designed to fulfil the intended purpose without errors and shall meets the current Good Manufacturing Practices (cGMP) requirements and all other regulatory obligations 3.0 Design Input 3.1 Purpose of System i) Clear statement of what the system is to do. ii) Expected benefits. iii) Relation to other system. 3.2 Controlled Function Operating Modes a) Automatic mode. b) Manual mode. c) Maintenance mode. d) Operational interlocks. Description of Operations. a) Sequence of operation. ...

1.0 Structural Codes Check if the Source Codes confirm to predefined Design Specifications. 2.0 Functionability a. Develop Test Data Sets with known Inputs and Outputs. The test data shall represent as much as possible Upper and Lower limit of intended use. However it shall also include Unusual Data (wrong case). b. Define the Test Environment i.e. place computer system to be used for testing. c. Define the Persons responsible for Testing (Number, Names, Qualifications, and Experience). d. Define the Errors and their Classification and Documentation. e. Define Release /Acceptance criteria before the test. f. Define the Testing Program as per follows. 3.0 Perform the test in predefined environment using predefined test persons. Only predefined test cases simulating as much as possible the real life environment shall be used. Record the results as per follows for each operation. Operator Name : Verslam Test :  4.0 Check the User Manual for a. If it describes Progra...

Validation of softwares during development is performed in three distinct stages: 1.       Validation of Design Inputs 2.       Validation of the Implementation stage 3.       Validation of Alpha and Beta Testing 1.0       VALIDATION OF DESIGN INPUTS 1.1       Design Specifications Prepared By                :           ________________ Approved By              :           ________________ Design Checked By    :           ________________ 1.2        Validation Report This shall include a.       ...

1.1 Data Access Prepare Test cases with slightly distrtal combination of Login ID and password and attempt access. Designated ID 1.2 Audit Trail 1.2.1 File to be checked : 1.2.2 Persons having access : 1..2.3 Data 1.3 Communication with Peripheral 1.3.1 Peripheral to be checked -Printer : 1.3.2 File to be checked : 1.3.3 File Size : 2.4 Data Integrity

1.0 DESIGN PARAMETERS 1.1 Define the Lan Model The Open System Interconnection (OSI) Others 1.2 Define the various protocols used The Physical Layer Transmits raw data bits over a communication channel (mostly mechanical and electrical issues) The Data Link Layer Guarantees to the network layer that there are no transmission errors by breaking the input data stream up into frames and sending back acknowledgement frames The Network Layer Controls the operation of the involved subnet; main issues are routing (determine a way from source to destination) and dealing with problems of heterogeneous networks, e. g. different size requirements of transmitted data blocks The Transport Layer Splits up data from the session layer if necessary (segmentation) and ensures that the pieces arrive correctly The Session Layer Allows users on different computer systems to establish a session between them, i. e. they are able to transfer files or log into a remote system; the conditions of c...

1.0               What is Computer Validation? The Food and Drug Administration of the USA defines Validation as “Establishing documented evidence that provides a high degree of assurance that a specific (computerized) process will consistently produce a product meeting its predetermined specifications and quality characteristics”. To simply put it: Identifying and documenting that the computer system does what it is supposed to do consistently, repeatedly, and accurately. 2.0               What comprise the Computer System? A device made up from electronics that can store and run a software-coded program. This includes all microprocessor based controllers, PLC, SCADA Systems, DCS, ERP, LIMS etc. 3.0               Why is Computer System Validation required? RISK Risk associated with the pati...

1.0               Define the inventory of Old Data -           Computer system where the data is located. -           Format of data.( Text, Graphics). -           Data Volume (MB, GB). -           Identify the Raw Data Formats used. -           Identify the different files and their contents. 2.0               Define the Importance of Data -           Archiving is compulsory under regulatory requirements. -           Data will need reanalysis / Recomputing in future. -           Data is required very oft...

1.0 Define the System 1.1 Describe the purpose. - Analytical Use. - Inventory / Store. - Archives / Records. - Management Information. 1.2 List of all Hardware. 1.1 List all Softwares. 1.4 List all Operational Parameters. 1.5 Define Requirements to Operator. 1.6 Define Security Requirements. - Hardware Lock - Password Access. - Biometric. - Hardware Lock + Password Access. 1.7 Check following parameters concerning to DQ - Purchase Order. - Certificates and specifications for Vendor. - Communications between internal users and Vendors. - Users Manual. - Maintenance, Calibration, and testing guidelines. - All Drawings. - List of Spares Supplied. 1.8 Check following parameters concerning OQ. - Date of Installation. - Installation Report. - Place of Installation. - Power Supply. - Safety aspects. - Calibration Details. - Functionability of all switches and ancillary devices such as Printer, Modem, LAN, FDD, ZDD. 1.9 Verify following matter concerning PQ - Security System. - Operat...