This category includes Stores and Ware house related sops of pharmaceutical plant

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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Transport Validation – Guideline & Protocol

Standard Operating Procedure (SOP) and Protocol for Transport Validation through temperature mapping during transit of drug products. Transport Validation Procedure 1.0   Objective To lay down the procedure for conducting transport validation and to describe acceptance criteria for the study. The purpose of this SOP is to provide detailed steps to conduct transport validation and to evaluate the product integrity 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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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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Failure Investigation Procedure and Tools

Standard Operating Procedure (SOP) for Failure Investigation (process failure as well as non-process failure) occurs during manufacturing or processing of drug products. Failure Investigation 1.0   Objective : To lay down the procedure for failure investigation of any activity to meet its predetermined specification, limits or acceptance criteria. 2.0   Scope : This SOP is applicable to process failure as well as…

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Raw Material Sampling Procedure-API & Excipient

Standard Operating Procedure (SOP) and Guideline for sampling of raw material (API and Excipient) / Starting material for analysis. Raw Material Sampling Procedure 1.0   Objective : To lay down a procedure for sampling of raw materials.  2.0   Scope : This SOP is applicable for sampling of raw materials at pharmaceutical drug manufacturing plant.           3.0   Procedure :…

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New Product Introduction Procedure and QRM

Standard Operating Procedure and Guideline for New Product Introduction in existing set of product list and equipment trail and Quality Risk Management at Pharmaceuticals Drug Manufacturing Plant. Guideline for  Introduction of Product 1.0   Objective : To lay down the procedure for introduction of new product at the manufacturing location. 2.0   Scope : This guideline is applicable for Introduction of new…

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Technology Transfer Procedure of Drug Product

Guideline for Technology Transfer. Tech Transfer is a systematic procedure that contains the transfer of any process together with its documentation and professional expertise between development and manufacture or between manufacture sites to produce similar quality products. It is a systematic procedure that is followed in order to pass the documented knowledge and experience gained during development and or commercialization…

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Quality Risk Management (QRM) – ICH Q9

Standard Operating Procedure (SOP) & Guideline for Quality Risk Management (QRM) i.e. risk identification, analysis, evaluation, reduction/ mitigation, communication and conclusion of risk in order to ensure the quality, safety, integrity and purity (SISPQ) of the drug product. Quality Risk Management (QRM) 1.0   Objective : To lay down the procedure for risk identification, analysis, evaluation, reduction/ mitigation, communication and conclusion…

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Corrective and Preventive Action (CAPA)

Standard Operating Procedure (SOP) for various investigation tools for finding the root causes that enables determination of corrective and preventive action (CAPA). Handling of Corrective and Preventive Action (CAPA) 1.0   Objective : To describe the procedure describing various investigation tools for finding the root causes that enables determination of corrective and preventive actions. To identify quality issues and GMP issues…

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APQR – Annual Product Quality Review in Pharma

Standard Operating Procedure for Annual Product Quality Review (APQR), also known as Product Quality Review (PQR) and Annual Product Review (APR) preparation. Procedure for Annual Product Quality Review (APQR) 1.0   Objective: To lay down the procedure for carrying out the Annual Product Quality Review (APQR). The purpose of this SOP is to describe the procedure for Product Quality Review (APQR)…

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Change Control Process and Management in Pharma

Standard Operating Procedure (SOP) for Procedure, Process and Management of Change Control (temporary change or permanent change control) in the pharmaceutical drug manufacturing plant. Change Control Management 1.0   Objective: To lay down the procedure to identify, initiate, evaluate, review, approve, implement, and regularize the change through a change control system. 2.0   Scope - SOP for Change Control: This procedure covers…

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Self Inspection & Internal Audit Procedure in Pharma

Standard Operating Procedure (SOP) for Self Inspection (Internal Audit) of various departments/sections and functions of the pharmaceutical drug manufacturing plant. Self Inspection (Internal Audit) Procedure 1.0   Objective : To lay down the procedure for conducting the self-inspection (Internal Audit) in order to implementation of  Quality Management System and compliance with GMP practice principles, Data integrity, and to propose necessary corrective…

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Self Inspection Checklist & Internal Audit Formats

Self Inspection (Internal Audit) Checklist for various departments/systems and functions of the pharmaceutical manufacturing plant. These checklists are applicable for inspection of the Company’s operations directly or indirectly connected with Manufacturing, Stores, Dispensing, Sampling, Packaging, Quality Control, Microbiology, Engineering,  IT, personnel, safety, Documentation, etc. Self Inspection Checklists List of Self Inspection (Internal Audit) Checklists - Stores & Ware House Self…

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Line Clearance of Process during Drug Manufacturing

Standard Operating Procedure (SOP) for Line Clearance (LC) during the manufacturing process of pharmaceutical drug products. The term line clearance is used for the documented act of conducting any necessary removal of products and materials from a manufacturing/ packaging line to prepare the line for the next production. Line Clearance (LC) Procedure 1.0   Objective : To lay down the procedure…

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