cGMP and Regulatory Updates

1. Objective: To describe the procedure for strip packing of Tablets/Capsules. 2. Scope: The procedure is applicable to strip packing machine. 3. Responsibility:  Operator: To follow  as per the written down procedure Packing Supervisor: To monitor and execute the written down procedure. Head of the Department: Implementation of procedure. 4. DEFINITIONS: Nil 5. REFERENCE: S.O.P. Guidelines 6. PROCEDURE: 6.1 Clean the hopper and chute with nylon brush or scrubber using 0.5% Sodium Lauryl Sulphate (SLS) solution. Clean with portable   water and Rinse with purified water and wipe it using a clean dry lint free cloth. Clean the vibrator with clean damp cloth and then with clean dry cloth. 6.2 Maintain the temperature and humidity if necessary as specified in Batch Manufacturing Record. 6.3 Set the rollers, chute, back gear, cutting gear suitable for the product to get desired Pack size.  Check the release status of Bulk tablets/filled capsule...

1. OBJECTIVE               To describe the procedure for cleaning of packaging equipments. 2. SCOPE           The procedure is applicable to cleaning of all the equipments used in packing. 3. RESPONSIBILITY Operator: To follow as per the written down procedure. Packing Supervisor: To monitor and execute the written down procedure. Head of Department: Implementation of the procedure 4. DEFINITIONS: Nil 5. REFERENCES.     S.O.P. Guidelines 6. PROCEDURE 6.1.      Before starting the packing of product, powder/dust shall be removed from the equipments             by using a vacuum cleaner. 6.2.      By means of vacuum cleaner, poly-bag sealers shall be cleaned followed by wiping with a             clean dry lint-free cloth. 6.3.       Cleaning of hand counters, plastic tubs, aluminum...

1. OBJECTIVE To describe the procedure for the accountability of the packing materials used for packing of a product. 2. SCOPE The  procedure  is  applicable  for  reconciliation  of  the  packing  materials  after completion  of packing. 3. RESPONSIBILITY Operator: To follow as per the written down procedure. Packing Supervisor: To monitor and execute the written down procedure. Head of Department: Implementation of the procedure 4. DEFINITIONS: Nil 5. REFERENCES. S.O.P. Guidelines 6. PROCEDURE 6.1. To know the quantities of all packing materials used after completion of a batch, below mentioned details are recorded in BMR. 6.1.1. Actual quantity issued. 6.1.2. Actual quantity used. 6.1.3. Quantity wasted or rejected on line. 6.1.4. Quantity  returned  to  Stores 6.1.5. Quantity of control  samples. 6.1.6. Quantity of reference sample. 6.1.7. Total of the above from 6.1....

1. OBJECTIVE           To describe the procedure about the packing of bulk tablets. 2. SCOPE       The procedure is applicable for packing of bulk tablets. 3. RESPONSIBILITY Operator: To follow as per the written down procedure. Packing Supervisor: To monitor and execute the written down procedure. Head of Department: Implementation of the procedure 4. DEFINITIONS: Nil 5. REFERENCES. S.O.P. Guidelines 6. PROCEDURE 6.1. Before starting the packing, the packing area shall be checked for proper cleaning. 6.2. Obtain line clearance from QA for starting of packing. 6.3. Only one product shall be taken for packing at a time. 6.4. Check that the labels on the bulk containers for the Product Name, Batch Number etc., is         matching with the printed packing materials. 6.5. Ensure the  approval of bulk tablets from Quality Control. 6.6. Check that all packing materials issued are approved ...

1. OBJECTIVE           To describe the procedure for cleaning of packing areas. 2. SCOPE       This procedure is applicable for the cleaning of Bulk packing area / Strip packing area / blister packing area / Strip sealing area/ blister sealing area. 3. RESPONSIBILITY Operator: To follow as per the written down procedure. Packing Supervisor: To monitor and execute the written down procedure. Head of Department: Implementation of the procedure 4. DEFINITIONS: Nil 5. REFERENCES. S.O.P. Guidelines  6. PROCEDURE 6.1.     Cleaning of bulk packaging area: 6.1.1.   By means of dry cloth and vacuum cleaner dust shall be removed from all the doors, windows, door joints, wall and wall corners and glass beadings. 6.1.2.   Thorough cleaning of floor is done by using cotton/synthetic wet mop with one percent liquid soap solution followed by 5% disinfectant solution.  Floor cleaning shall be don...

1. PROCEDURE: To describe the procedure for packing of Blisters/strips. 2. SCOPE: The procedure is applicable for secondary packing of blister/strips. 3. RESPONSIBILITY: Operator: To follow as per the written down procedure. Packing Supervisor: To monitor and execute the written down procedure. Head of Department: Implementation of the procedure 4. DEFINITIONS: Nil 5. REFERENCES: S.O.P. Guidelines  6. PROCEDURE: 6.1 Before starting the packing, the packing area shall be checked for proper cleaning. 6.2 Ensure previous batch materials are removed from the area. 6.3 Obtain line clearance from QA before starting of the packing. 6.4 Only one product shall be taken for the packing at a time. 6.5 Obtain approval for blisters/strips from the quality control. 6.6 Check that all packing material issued, are approved by the quality control. 6.7 Overprinted packing materials are subjected to 100% inspection for the correction of Batch No, Mfg Date, Exp....

1. OBJECTIVE: To describe the procedure for dedusting and inspection of tablets. 2. SCOPE: The procedure is applicable to dedusting and inspection of tablets. 3. RESPONSIBILITY: Operator: To follow as per the written down procedure. Packing Supervisor: To monitor and execute the written down procedure. Head of Department:  Implementation of the procedure 4. DEFINITIONS: Nil 5. REFERENCES: S.O.P. Guidelines 6. PROCEDURE: 6.1 Before starting the dedusting/inspection of the tablets, dedusting area shall be cleaned properly by using cotton/synthetic wet mop with 1% liquid soap solution followed by 5% of disinfectant solution. 6.2 Cleaning of the plastic tubs shall be done by using 0.5% Sodium Lauryl Sulphate solution and then washed with the potable water followed by purified water and then finally wipe with clean dry lint-free cloth. 6.3 Obtain line clearance from QA for dedusting/inspection of the product. 6.4 Switch on the dedusting machine and put ta...

1.0 OBJECTIVE : To  provide  the  procedure  for  allotting  lot  numbers  to  volumetric solutions, buffer  solutions, test  solutions, HPLC mobile phases and Primary standards. This system helps in identifying the solutions used in Analytical Development  laboratories. 2.0 RESPONSIBILITY : 2.1 Analytical Development officer whoever prepares these solutions to allot the lot number. 2.2 AR&D Manager to ensure compliance. 3.0 PROCEDURE : 3.1 Volumetric Solutions 3.1.1 Prepare  volumetric  solutions as mentioned in...