This category includes Quality Control SOP’s,

Top Loading Balance – Operation and Calibration SOP

Standard Operating Procedure for Operation and Calibration of Top Loading Balance used in the pharmaceutical industry, guideline, and formats of uses and calibration/qualification. Operation & Calibration Procedure for Top Loading Balance 1.0   Purpose : To lay down a procedure for Operation and Calibration of Top Loading Balance. 2.0   Scope :  This SOP is applicable for Top Loading Balance used in…

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Data Integrity Incident Handling Procedure

Standard Operating Procedure (SOP) for Handling of Data Integrity Incident Investigation and compliance in Pharmaceutical Drug Manufacturing Plant. Handling of Data Integrity Incident 1.0   PURPOSE: To provide a procedure to investigate and handle data integrity incidences related to GXP data, identified during internal audit or during review of data. 2.0   SCOPE: Applicable to all GxP data generated by electronic and…

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Documents and Data Control in Pharmaceuticals

Documents and Data Control is a function or department which keeps track of all documentation, specifications, and processes. The purpose is to ensure that everyone uses the correct and current document processes and specifications. Documents and Data Control 1.0   Objective To lay down a procedure for control of documents and documented data. 2.0   Scope This SOP is applicable for the…

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Reprocessing Reworking & Redressing of Product

Reprocessing and reworking are considered non-routine events. Reprocessing: reprocessing is the introduction of an in-process material or drug product including one that does not conform to a standard or specification back into the process and repeating steps that are part of the approved manufacturing process / Primary packaging process. Continuation of a process step after a process test has shown…

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Tech Transfer Documents Handling Procedure

Standard Operating Procedure for the handling of Tech Transfer documents received from transferring unit (TU)/ generated at receiving unit (RU) during tech transfer activity. Tech Transfer Documents 1.0   Objective To lay down the procedure for Handling Tech transfer documents for the products to be introduced/transferred at the site. 2.0   Scope This SOP is applicable to all Technology transfer (Tech Transfer)…

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GC Columns (Gas Chromatography) Management

Standard Operating Procedure for Receipt, Issuance, Performance, Regeneration, Use, Cleaning, Storage and Rejection of GC Columns. GC Column Management 1.0   Objective To lay down the procedure for Receipt, Issuance, Performance, Regeneration, Use, Cleaning, Storage and Rejection of GC Columns. 2.0   Scope This SOP is applicable for all the GC columns used in Quality Control Laboratory 3.0   Procedure for GC Columns…

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Reduce Testing Procedure for Raw Material (API)

Standard Operating Procedure (SOP) for Reduce Testing in pharmaceutical starting materials (Raw Material) procured from approved vender. Reduce Testing Procedure 1.0   Objective To lay down a procedure for reduce the testing of raw materials. 2.0   Scope This SOP is applicable for Reduce Testing of raw materials procured from approved vender. 3.0   Procedure for Reduce Testing: Reduced Testing shall be done…

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Equipment Qualification Procedure and Protocol

Equipment Qualification is the final series of inspections and tests to ensure that critical requirements necessary for related product quality are satisfied and that documents and procedures necessary to properly operate and maintain the system are in place. Equipment Qualification Procedure 1.0   Objective : To lay down the procedure for preparation of Qualification documents, execution of Qualification activities, Review and…

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Finished Product Release Procedure (SOP)

Standard Operating Procedure (SOP) for Finished Drug Product (Finished Goods) Release for Sale and Distribution including the review of batch documents and checkpoints. Finished Drug Product (Finished Goods) Release 1.0   Objective :  To lay down the Procedure for release of Finished Products for sale & distribution. 2.0   Scope : This procedure is applicable to all products manufactured at pharmaceutical drug…

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In Process Quality Assurance (IPQA) Check Points

Standard Operating Procedure (SOP) for In - Process Quality Assurance (IPQA) check points and procedure during manufacturing of drug product in pharmaceuticals. In process Quality Assurance (IPQA) Checks 1.0   Objective : To lay down procedure for monitoring the In - Process Quality Assurance (IPQA) activities in stores and Production. 2.0   Scope : The SOP is applicable in stores and production…

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Out of Specification (OOS) Handling Procedure

Guideline for Handling of Out of Specification (OOS) results occurs during analysis of Raw Material and Pharmaceutical Drug Products (Different stages like - In-process, Bulk, Intermediate, Finished Product & Stability Study Samples) Handling Out of Specification (OOS) Results 1.0   Objective : To lay down the procedure for investigation of Out of Specification (OOS) result(s) that occurs during sample testing in…

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Vendor Audit & Qualification Management Procedure

Vendor Audit is an evaluation of vendor's manufacturing site, for product of interest(s), for the understanding and application of the cGMP. Successful evaluation of Vendor’s ability and capability in meeting the company’s quality system requirements in relation to the criteria established for the material being sourced. Vendor Audit and Qualification Guideline 1.0   Objective : To lay down a procedure for…

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Stability Chamber / Incubator Management Procedure

Standard Operating Procedure (SOP) for Management of Walk in and stand-alone Stability Chamber used for Stability Study and also to determine the self life of the drug product. Stability Chamber / Incubators Management 1.0   Objective : To lay down a procedure for Management of Walk in and stand-alone Stability Chamber. 2.0   Scope : This SOP is applicable for Management of…

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Cleaning Validation : Procedure & Protocol

Standard operating Procedure & Protocol for Cleaning Validation to prove that the equipment cleaning procedure can repeatedly and reproducibly remove residue of the previous product below established acceptance limit. The acceptance limit is maximum allowable quantity of product residue, which does not affect quality and safety of the subsequent product to be manufactured, by using same equipment and facility. Cleaning…

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Method Verification (Analytical) Procedure (USP1226)

Standard Operating Procedure for performing analytical method verification of compendial procedure/ validated analytical methods in quality control department. Describes characteristics for analytical method verification to be carried out for drug substances and drug products. Analytical Method Verification 1.0   Objective : To lay down the procedure for performance of analytical method verification of compendial procedure/validated analytical methods in quality control department.…

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Laboratory Glassware Cleaning of Procedure

Standard Operating Procedure (SOP) for Cleaning of Laboratory Glassware. Occasionally, more aggressive cleaning solutions may be necessary when laboratory glassware is extremely dirty. These solutions are often highly corrosive, involving concentrated acids or bases, and can cause injury. Cleaning of Laboratory Glassware 1.0   Objective : To lay down a procedure for cleaning of laboratory glassware.  2.0   Scope : This SOP…

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Viscometer – Operation and Calibration Procedure

Standard Operating Procedure (SOP) for Operation and Calibration of Brookfield make Viscometer used to determine the viscosity of solution / suspension / liquids in Quality Control department. Viscometer (Brookfield) - Operation and Calibration Procedure 1.0   Objective : To lay down a procedure for operation and calibration of viscometer. It is used to determine the viscosity of solution / suspension /…

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Polarimeter – Operation and Calibration Procedure

Standard Operating Procedure (SOP) for Operation and calibration of Polarimeter used to determine of optical rotation of raw material in Quality Control. Procedure for Polarimeter - Operation and Calibration 1.0   Objective : To lay down a procedure for operating and calibration of Polarimeter. It is used to determine the optical rotation of material. 2.0   Scope : This SOP is applicable…

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UV-Visible Spectrophotometer – Calibration

Standard Operating Procedure (SOP) for Operation and Calibration of UV-Visible Spectrophotometer used for Qualitative and Quantitative analysis of starting material (RM-API & Excipient), water analysis and drug product. UV-Visible Spectrophotometer 1.0   Objective : To lay down a procedure for operation and calibration of UV-Visible Spectrophotometer. It is used for qualitative & quantitative determination of substances. 2.0   Scope : This SOP…

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