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SOP on Drug Product Recalls

SOP on Drug Product Recalls OBJECTIVE : To define the procedures used to effect the recall of a marketed product once it has been decided that such a course of action is required. RESPONSIBILITY : The  Managing  Director  and  Divisional  Head  shall be responsible for making the  decision  that  a  …

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Issuance and Evaluation of Product Exception Investigation Reports (“EIRs”).

Issuance and Evaluation of Investigation Reports OBJECTIVE : To establish a documentation system by which qualified representatives report  and investigate the exceptions of drug products in the manufacturing process, in-process specifications. RESPONSIBILITY : Executive – Production/Packaging to prepare the Exception Investigation Report (EIR). Head – Production to investigate and implement …

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SOP on Process Validation Programmed in Pharmaceutical Company

SOP on Process Validation Programmed in Pharmaceutical Company OBJECTIVE : To lay down the procedure for the process validation of products to ensure that a specific process will consistently produce the product meeting its pre-determined specifications and quality attributes. RESPONSIBILITY : Research  Development to prepare and execute the validation protocol …

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Preparation, Approval, Issue and Control of Art works for labeling of Pharmaceutical products

Preparation, Approval, Issue and Control of Art works for labeling of Pharmaceutical products OBJECTIVE : To lay down the Procedure for Preparation, Approval, Issue and Control of  art works for labeling of pharmaceutical products. RESPONSIBILITY : R&D(Packaging Development) to prepare the Art work, positives or soft copy, and procure shade …

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Procedure for calibration of weighing balances

Procedure for calibration of weighing balances OBJECTIVE To lay down a procedure for calibration of weighing balances. SCOPE The Standard Operating Procedure is applicable to In process Quality Assurance areas. RESPONSIBILITY Concerned Technician ACCOUNTABILITY Inprocess Quality Assurance Executive/ Officer. PROCEDURE DAILY CALIBRATION Before calibrating the balance, clean the weighing platforms. …

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Calibration procedure for halogen moisture analyser

Calibration procedure for halogen moisture analyser OBJECTIVE To lay down the procedure for calibration of Halogen moisture analyser, SCOPE This SOP shall provide the calibration procedure of Halogen moisture analyser in in-process quality assurance department and quality control department. RESPONSIBILITY Officer/ Executive – Quality Control/Quality Assurance. ACCOUNTABILITY Head QC/QA PROCEDURE …

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Handling of Returned Pharmaceutical Products

Handling of Returned Pharmaceutical Products OBJECTIVE : To establish procedure for Inspection and Handling of Returned Drug Products,l. 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 the received …

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Procedure for calibration of disintegration test apparatus (SAPO)

OBJECTIVE To lay down a procedure for Calibration of Disintegration test apparatus (SAPO). SCOPE This Standard Operating Procedure (SOP) is applicable to DT apparatus . RESPONSIBILITY IPQA / Production Executive / Officer ACCOUNTABILITY Head –Quality Assurance PROCEDURE Check the water level in the water bath. Fill the water in the …

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Procedure for calibration of Autotitrator (METTLER TOLEDO)

OBJECTIVE To lay down the procedure for Calibration of Autotitrator  (METTLER TOLEDO DL50). SCOPE This SOP shall be applicable for the Autotitrator (METTLER TOLEDO DL50). RESPONSIBILITY Quality Control Executive/Officer. ACCOUNTABILITY Head Quality Control. PROCEDURE FOR CLEANING Check that the power supply to the instrument is switched ‘ OFF ‘ before …

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Procedure for calibration of calculator. Quality assurance

OBJECTIVE To lay down the Procedure for Calibration of calculator. SCOPE This SOP provides guidance to calibrate the calculators, which are used for simple and complex calculations of analysis in quality control department. Scientific calculator Desktop calculator Calculator used in the computer (Windows Version 98, 2000, 2003, XP both standard …

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Review and Change Control of Formats

OBJECTIVE : To lay down the procedure for review and change control of formats originated through Standard Operating Procedures (SOPs). This procedure is applicable for review and change control of formats in the instances, where only the respective format(s) required to be reviewed, with out revising the SOP  for better …

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Calibration procedure for pH meter

OBJECTIVE To describe the calibration procedure for   pH meter. SCOPE This SOP shall be applicable for the calibration procedure for pH meter RESPONSIBILITY Quality Control Executive/Officer. ACCOUNTABILITY Quality Control   Manager PROCEDURE Operate the Instrument as per procedure. Insert the pH electrode and temperature sensor in buffer solution pH 4.0 Press …

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SOP On Change Control In pharmaceutical company

OBJECTIVE : A  procedure to ensure that no changes  are  made in   any    approved    pharmaceutical  product’s, manufacturing    process, GMP   related equipment / facility / utility, computer system, Standard Operating  Procedures (SOPs), Standard  Cleaning  Procedures (SCPs), Master Production Records, specifications, standard test procedures, vendor of raw materials and Primary / …

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SOP on Handling of Market complaints

OBJECTIVE : To establish a procedure to investigate, document, respond and review of  all product related complaints received RESPONSIBILITY : Quality Assurance department to process and respond to all product complaints. Head – RA to co-ordinate with concerned Regulatory Authority. Head of Quality Assurance Department to ensure compliance. PROCEDURE Every  …

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Control of Completed Batch Production. Quality Assurance

OBJECTIVE : To provide a procedure for the proper control of completed Batch Production Records (BPR) after release of finished drug products for distribution. RESPONSIBILITY : Officer – Quality Assurance. Officer – Documentation. Head of Quality Assurance Department to ensure compliance. PROCEDURE All completed Batch Production Records (BPR) duly approved …

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Review of Batch Production Records

Review of Batch Production RecordsOBJECTIVE : To provide a procedure for the review of Batch production Record (BPR) before  release  of  drug  products, in order  to verify the compliance with cGMP  requirements   and   all   established  specifications  and  written procedures in the manufacturing of the product batch. RESPONSIBILITY :  Quality Assurance …

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Release of Finished Products

OBJECTIVE : To lay down procedure for QA release of Finished Product for distribution. RESPONSIBILITY : Quality Assurance Officer. Head of Quality Assurance Department to ensure compliance. PROCEDURE : After receiving Finished Product Release Report (FRR)  (Annexure – 1) from Production Department, QA – Officer shall check the following. All  …

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Process Area clearance during batch/product changeover

OBJECTIVE : To provide procedure for  Process area  clearance during batch/product change over. RESPONSIBILITY : Officer Quality Assurance  for implementation Head of Quality Assurance Department to ensure compliance. PROCEDURE : Note: Type-A  Area clearance : During batch change over of same product. Type-B  Area clearance : During batch change over …

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Assigning of repack before date

OBJECTIVE : To lay down the procedure for assigning of ‘repack before date’. RESPONSIBILITY : Officer  Production/Officer Quality Assurance Head – Quality Assurance to ensure compliance. PROCEDURE The ‘repack before date’ shall be assigned from the day packing is initiated. The basis for period of repack before shall be on …

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SOP on Cleaning of Sampling Aids

OBJECTIVE : To lay down a procedure for cleaning of 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 980 mL of potable water …

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