Handling of Returned Pharmaceutical Products OBJECTIVE : To establish a procedure for the Inspection and Handling of Returned Drug Products. RESPONSIBILITY : Head – Warehouse to inform Head QA about the product returned. Officer Warehouse to identify the product returned, against documents received and to verify the physical conditions of …
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 »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 »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 »SOP On Document and Data Control
SOP On Document and Data Control Objective: To lay down a procedure for control of documents and documented data. Scope: This Standard Operating Procedure is applicable for the control of documents and documented data at the formulation plant of Pharmaceuticals Company Name with Location. Responsibility All HODs shall be responsible …
Read More »SOP on sterilization of garment and surgical hand gloves
Objective To lay down a procedure for sterilization of garments and surgical hand gloves. Scope This SOP is applicable for sterilization of garments and surgical hand gloves. Responsibility Production Officers /Executive. Accountability Production Head shall be accountable for the compliance of SOP. Abbreviations SOP : Standard Operating Procedure. LAF : …
Read More »SAMPLING AND ANALYSIS OF WATER/PURE STEAM FOR MICROBIOLOGY LAB
SAMPLING AND ANALYSIS OF WATER/PURE STEAM FOR MICROBIOLOGY LAB PURPOSE: To lay down the procedure for Sampling and analysis of Water/Pure steam for Microbiology Lab. SCOPE: This SOP is applicable to provide the instructions and guidance for Sampling and analysis of Water/Pure steam for Microbiology Lab. RESPONSIBILITY: Microbiologist Person shall …
Read More »SOP on cleaning during media fill trials and decontamination after completion of media fill trials
Objective: To lay down a procedure for cleaning during media fill trial and decontamination after completion of media fill trials. Scope: This SOP describes the procedure for cleaning during media fill trials and decontamination after completion of media fills trials. Responsibility: Production Officers / Executive. Accountability: Production Head shall be …
Read More »Lilly Alzheimer’s Drug Can Save Dismal Year for Pharma
Upcoming results from late-stage data will have major impact on sector By CHARLEY GRANT Updated Nov. 22, 2016 5:06 p.m. ET After a year of drama for the health-care industry, ranging from the EpiPen pricing scandal to the collapse of Valeant Pharmaceuticals International and Theranos to the unknown future of Obamacare …
Read More »SOP for cleaning and sanitization of controlled area
Objective: To lay down a procedure for cleaning and sanitization of controlled area. Scope: This SOP is applicable for cleaning and sanitization of controlled area. Responsibility: Production Officer / Executive. Accountability: Production Head shall be accountable for compliance of SOP. Abbreviations SOP : Standard Operating Procedure. S.S. : Stainless Steel …
Read More »SOP on Batch preparation of vial filling process.
Objective: To lay down a procedure on Batch Preparation of vial filling process. Scope This SOP is applicable for batch preparation of vial filling process.. Responsibility Production Officers / Executive. Accountability Production Head shall be accountable for the compliance of SOP. Abbreviations SOP : Standard Operating Procedure. RM : Raw …
Read More »SOP on operation and cleaning of Pneumatic Lifting Table & Visual Inspection machine
Objective To lay down the procedure of operation and cleaning of Pneumatic Lifting Table & visual Inspection machine. Scope This SOP is applicable for the operation and cleaning of Pneumatic Lifting Table & Visual Inspection used in the vial decartoning room of the sterile Injectable facility. Responsibility Production officer / …
Read More »SOP for cleaning of strapping machine
SOP for cleaning of strapping machineObjective: To lay down a procedure for cleaning of strapping machine. Scope This SOP is applicable for cleaning of Strapping machine. Responsibility Officers or above – Production. Accountability Production Head. Abbreviations SOP : Standard Operating Procedure. Procedure The cleaning of Strapping machine is to be …
Read More »SOP for cleaning of BOPP taping machine
Objective To lay down a procedure for cleaning of BOPP taping machine. Scope This SOP is applicable for cleaning of BOPP taping machine. Responsibility Officers or above – Production. Accountability Production Head. Abbreviations SOP : Standard Operating Procedure. BOPP : Biaxial Oriented Polypropylene IPA : Isopropyl Alcohol Procedure The cleaning …
Read More »SOP for cleaning of inkjet printing machine
Objective: To lay down a procedure for cleaning of Ink Jet printing machine. Scope This SOP is applicable for the cleaning Ink jet printing machine. Responsibility Officers or above – Production. Accountability Production Head. Abbreviations SOP : Standard Operating Procedure. Cleaning Procedure Press “ON/OFF” switch and wait for two minutes. …
Read More »