GENERAL PRECAUTIONS DURING PRODUCTION ACTIVITY

PRECAUTIONS DURING PRODUCTION ACTIVITY

v  Dispensing of all the raw materials should be done in dispensing area, which should be maintained 

v  Clean, dust free and hygienic to prevent contamination. Dispensed raw material should be labeled and 

v  Signed by store, production and QA person to ensure correct quantity. Follow SOP of Dispensing of 

v  Raw Materials (As per SOP No.).  

v  Ensure that all the cleanable filters are cleaned as per their schedule.

v  All the dispensed raw materials should be moved in double lined poly bags duly labeled and then to be 

v  Stored in the SS dispensing box and label shall be affixed (As per SOP No.).

v  Manufacturing process or any operation in the manufacturing process should not be started until the prescribed environmental conditions are within limits. Follow SOP of Monitoring of Temperature and Relative Humidity (As per SOP No.).

v  Filtration, filling and sealing activity shall be carried out under sterile conditions.

v  Use Nose Mask, Hand Gloves and Safety Goggles etc. protective apparels to prevent contamination from human body as well as to protect from micronized dust particles of the material being handled during the entire operation.

v  Entire operation shall be carried out as per the above stated precautions and in BMR. No deviation is permitted. If at all violation of the standard procedure is to be made prior authorization is necessary so that if the new procedure is beneficial, the standard procedure can be modified according to change control procedure (As per SOP No.). and handling of temporary change procedure (As per SOP No.)

v  Make neat and clean records, sign the records only after ensuring the operation has been carried out. Do          not obliterate the mistake, instead cross the wrong reading. Follow SOP of GDP (As per SOP No).

PACKAGING CONDITIONS AND PRECAUTIONS

v  Entire operation shall be carried out as per GMP and SOP of Packing of Batch (As per SOP).

v  Make neat and clean records, sign the records only after ensuring the operation has been carried out. 

v  Do not obliterate the mistake, instead cross the wrong reading. Make the correct entry and then sign     or write initial with the date and reason for correction, if possible. Follow SOP of GDP (As per SOP No.).

v  Utmost care to be exercised for dispensing of printed packaging materials.

v  Packaging process or any operation in the packaging should not be started until the prescribed   

v  Environmental conditions are within limit. Follow SOP of Monitoring of Temperature and Relative  

v  Humidity (As per SOP No).

v  Entire operation shall be carried out as per the above stated precautions and in BPR. No deviation is permitted. If at all violation of the standard procedure is to be made prior authorization is necessary so that if the new procedure is beneficial, the standard procedure can be modified according to change control procedure (As per SOP No). And handling of temporary change procedure (As per SOP No).

  Scrap generated of rejected labels during packaging operation shall be destroyed.

PACKAGING PROCEDURE AND IN-PROCESS CONTROLS

Packaging Procedure:

v  Send all the optically good vials to the packing department.

v  Ensure that all secondary / tertiary packaging materials like Cartons, Labels, Box labels, Literatures of 

v  Previous product / batch are removed before taking new batch.

v  After receiving the printed label from packaging material store.

v  Start the packing of the batch as per SOP No.              

v  QA person shall withdraw the control samples (As per SOP No) and stability samples (As per SOP No.) (whenever applicable) randomly at the start, middle and at the end of packing of batch.

v  At the end of the packaging, packing supervisor shall give Intimation docket of finished product with   

v  Sample to QC through IPQA person for analysis.

v  After release of batch from QC, the batch shall be transferred from quarantine area to approved area

v  In FG warehouse.

v  QA person shall collect samples from FG (As SOP No.) quarantine on intimation or as     per planning of stability schedule.

v  Affix label on bottom right corner of corrugated box with a stamp mentioning the quantity.

v  In-process Controls:

v  In-process checks shall be done as per SOP No.

v  Check labeling quality every hour and In-process checks of shippers every hour.