SOP on Cleaning of Sampling Aids OBJECTIVE : To lay down a procedure for cleaning Sampling Aids. RESPONSIBILITY : Officer – Quality Quality Assurance to implement the procedure. Head – Quality Quality Assurance to ensure compliance. PROCEDURE : Preparation of Detergent solution (2% Extran MA 02 Neutral, solution). To about …
Read More »SOP on Annual Product Review of Drug Product Quality (APQR)
SOP on Annual Product Review of Drug Product Quality (APQR) OBJECTIVE : To establish a procedure for the preparation, review, and approval of Annual product reviews to assure the consistent and acceptable quality of each product manufactured for distribution and apprise upper management of any changes needed. RESPONSIBILITY : Officer …
Read More »SOP on Cleaning Validation in pharmaceutical company
SOP on Cleaning Validation in a pharmaceutical company OBJECTIVE : To establish and explain the procedure to be followed for the cleaning Validation of Standard Cleaning Procedures (SCP)s, in order to Assure that the fitness of the equipment is adequately protected for every product. Demonstrate that no cross-contamination will be …
Read More »Reporting, Investigating and Disposition of Incidents
Reporting, Investigating, and Disposition of Incidents OBJECTIVE : To lay down a procedure for reporting, investigating, and disposition incidents in the Quality Assurance Department. RESPONSIBILITY : Officer-QA to raise Incident Report to allot number & due date to the Incident Report. Officer-QA & Head-QA or his designee to investigate and …
Read More »Packaging Area/Line Clearance during batch/product change over
OBJECTIVE : To outline the procedure for the Packaging Area/Line clearance before the start up of any packaging operation, to ensure that the packaging area/line has been thoroughly cleaned and that all coded labeling and packaging materials of the previous batch/product have been completely removed. RESPONSIBILITY : Officer – Production …
Read More »Cleaning of Unit Dose and Large Volume Sampling Thieves
Cleaning of Unit Dose and Large Volume Sampling Thieves OBJECTIVE : To lay down the procedure for cleaning unit dose and large volume sampling thieves. RESPONSIBILITY : Executive -Quality Assurance to implement the procedure. Head – Quality Assurance to ensure compliance. PROCEDURE : Preparation of Detergent solution (2% Extran MA …
Read More »FDA Form 483 Frequently Asked Questions
Q: When is an FDA Form 483 issued? A: An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgement may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts. FDA …
Read More »Responsibilities of Quality Assurance Department
Responsibilities of the Quality Assurance Department OBJECTIVE : To lay down the responsibilities of the Quality Assurance Department. RESPONSIBILITY : All personnel of the Quality Assurance Department. Head of Quality Assurance Department to ensure compliance. PROCEDURE : The Quality Assurance department shall be responsible to formulate systems for the implementation …
Read More »Procedure for calibration of HPLC (WATERS ALLIANCES)
Procedure for calibration of HPLC (WATERS ALLIANCES) In the pharmaceutical industry, where precision and accuracy are non-negotiable, High-Performance Liquid Chromatography stands as a stalwart technology. From drug development to quality control and regulatory compliance, HPLC plays a vital role in ensuring the safety, efficacy, and consistency of pharmaceutical products. As …
Read More »Procedure for operation of IR Spectrophotometer (SHIMADZU)
OBJECTIVE To lay down the procedure for operation of Fourier Transform Infrared Spectro-photometer (Shimadzu) SCOPE This SOP shall be applicable for Quality Control in Quality Assurance department. RESPONSIBILITY Quality Control Executive/Officer. ACCOUNTABILITY Quality Control Manager. PROCEDURE FOR CLEANING Check that the power supply to the instrument is switched ‘ OFF …
Read More »Collection, Storage and Control of Reserve Samples for Drug Products
Collection, Storage, and Control of Reserve Samples for Drug Products OBJECTIVE : To lay down a procedure for collection, storage, retrieval, and disposition of reserve samples of drug products. RESPONSIBILITY : Quality Assurance Officer for collection, storage, retrieval, and disposal of reserve samples. Head of Quality Assurance Department to ensure …
Read More »Correction of Documentation Errors
OBJECTIVE : To provide a procedure for correction of any documentation error, occurred during documenting data in operating departments (like Quality Control, Production, Warehouse, Engineering, QA) RESPONSIBILITY : Personnel of concerned department to implement. Heads of concerned departments to ensure compliance. PROCEDURE : All personnel shall avoid making data entry …
Read More »In-process checks during Packaging Operation of tablets and capsules
OBJECTIVE : To lay down the procedure for in-process checks during the packaging operation of tablets and capsules. RESPONSIBILITY : Officer-Production Packaging. Head of Production Department. Officer-Quality Assurance Head of Quality Assurance Department to ensure compliance. PROCEDURE Inspection of Packaging Materials : The production Officer and QA-Officer shall check that …
Read More »Installation qualification for WFI generation plant
Installation qualification for WFI generation plant Customer or their authorized representatives are responsible for this SAT document. All documents shall be checked and approved by QA or their authorized representatives. Production personnel will perform this test. OBJECTIVE To confirm, by physical inspection and testing, that the fabrication and assembly of …
Read More »Assigning of expiry date to a finished product
OBJECTIVE : To lay down the procedure to assign expiry date to a finished product. RESPONSIBILITY : Officer Production/Officer Quality Assurance Head – Quality Assurance to ensure compliance. PROCEDURE Manufacturing date : The date of manufacture of the batch shall be the date on which an active ingredient has been …
Read More »Technical training and evaluation of Quality Assurance Officers.
OBJECTIVE : To lay down the procedure for training and evaluation of QA Officers on SOPs and cGMP. RESPONSIBILITY : Personnel who are knowledgeable with the subject by virtue of their qualification and experience. Head -Quality Assurance to ensure compliance. PROCEDURE : All Quality Assurance Officers shall undergo training and …
Read More »SOP on In-process control of packing Process in Pharmaceutical company
OBJECTIVE To ensure quality of Finished Products during strip packing and final packing operation of tablets. SCOPE This SOP shall be applicable in-process controls during primary and secondary packing operation of tablets. RESPONSIBILITY In process Quality Assurance Officer / Executive. ACCOUNTABILITY Head Quality Assurance PROCEDURE START UP Inspect the following …
Read More »SOP on Procedure for microbiological monitoring of Purified water in pharmaceutical company
OBJECTIVE To lay down a procedure for microbiological monitoring of raw water and purified water SCOPE: This SOP shall be applicable for sampling and microbial analysis of raw and purified water from all user points. RESPONSIBILITY Quality Control Executive / Officer ACCOUNTABILITY Quality Assurance Head. PROCEDURE: Sampling of water Sampling …
Read More »SOP on Procedure for viable air monitoring in pharmaceutical company
SOP on Procedure for viable air monitoring in pharmaceutical company OBJECTIVE To lay down a procedure for environmental monitoring of air. SCOPE This SOP shall provide the procedure for monitoring the viable air borne count. RESPONSIBILITY Quality Control Executive / Officer. ACCOUNTABILITY Head Quality Assurance. PROCEDURE The microbial environmental conditions …
Read More »SOP on In-process control during tablet manufacturing in Pharmaceutical company
OBJECTIVE To lay down the procedure for In-process Controls during Tablet Manufacturing. SCOPE This SOP shall be applicable for in-process controls during tablets manufacturing This SOP shall be applicable to IPQA in Quality Assurance Department. RESPONSIBILITY In process Quality Assurance Executive/Officer. ACCOUNTABILITY Head Quality Assurance. PROCEDURE Carry out line clearance at …
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