SOP on Cleaning Validation in pharmaceutical company

SOP on Cleaning Validation in 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  fitness of the equipment is adequately protected for every product.  Demonstrate that no cross contamination will be observed on shared equipment between drug … Read more

Reporting, Investigating and Disposition of Incidents

OBJECTIVE : To lay down a procedure for reporting, investigating and disposition of incidents in 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 to dispose the incident. PROCEDURE An … Read more

Cleaning of Unit Dose and Large Volume Sampling Thieves

OBJECTIVE : To lay down the procedure for cleaning of 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 980 mL of potable water in plastic beaker … 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

OBJECTIVE : To lay down the responsibilities of  Quality Assurance Department. RESPONSIBILITY : All personnel of Quality Assurance Department. Head of Quality Assurance Department to ensure compliance. PROCEDURE : Quality  Assurance  department  shall   be  responsible to formulate systems for the implementation of cGMP and, to ensure the preparation, approval and implementation  of  Standard   Operating   Procedures, … Read more

Procedure for calibration of HPLC (WATERS ALLIANCES)

OBJECTIVE To lay down the procedure for calibration of the HPLC (Waters Alliances 2695, Separation Modules). SCOPE To ensure that the calibration procedure of HPLC meets the acceptances criteria. This SOP shall be applicable for the HPLC system. (WATERS Alliances 2695 Separation Modules). RESPONSIBILITY Quality Control Executive/Officer. ACCOUNTABILITY Quality Control Manager. PROCEDURE FOR CLEANING Check … 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

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 of each drug product in all forms of its packing … 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

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