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 – Quality Assurance to compile … 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 observed on shared equipment between … 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 take necessary corrective actions. Head-QA … 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  Packaging Officer – Quality Assurance … 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 02 Neutral, solution): To about … 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 investigators are trained to ensure … 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 of cGMP and, to ensure … 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 technology continues to advance, HPLC … 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 ‘ before cleaning. Clean the … 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 compliance. PROCEDURE : Every batch/lot … 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 errors. In case an 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 the packaging components issued  (containers, … Read more

Installation qualification for WFI generation plant

Installation qualification for WFI generation plant  RESPONSIBILITES Inspection  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 personal will perform this test. OBJECTIVE To confirm, by physical inspection and testing, that the fabrication and assembly of the equipment and … 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 added to a batch. Expiry … 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 qualify on relevant/appropriate   Standard Operating   … 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 areas as per SOP  for … 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 of water from various points … 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 shall be monitored by Settle … 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 each stage of operation prior … Read more

SOP on Sampling of intermediates and finished products in pharmaceutical company

OBJECTIVE To lay down a procedure for sampling of intermediate(blend/core/coated/capsules) and finished products (packing)during manufacturing operations. SCOPE This SOP shall be applicable to the IPQA in Quality Assurance Department. RESPONSIBILITY In process Quality Assurance Executive/Officer ACCOUNTABILITY Head Quality Assurance PROCEDURE PREPARATION On completion of intermediate / finished product stage, check that the BMR /BPR is … Read more