This category includes Maintenance and engineering 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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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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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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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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Vibro Sifter – Procedure for Cleaning and Operation

Standard Operating Procedure for Cleaning and Operation of Vibro Sifter. Pharmaceutical Vibro Sifter is used to separate mass composition of solids, liquid from solid and grading the material as per particles size. It is a type of pharmaceutical machine used for separation of pharmaceutical solids or liquids. Vibro Sifter - Operation & Cleaning 1.0   Objective To lay down the procedure for cleaning & operation of…

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Tablet Compression Machine – Operation & Cleaning

Standard Operating Procedure for Operation and Cleaning of Tablet Compression Machine, the basic principle behind the compression machine is the hydraulic pressure. Tablet Compression Machine 1.0   Objective : To lay down the procedure for cleaning and operation of Tablet Compression Machine (35 Station).        2.0   Scope : This SOP is applicable in Manufacturing Area Tablet at pharmaceutical drug manufacturing plant. 3.0 …

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Moisture Analyzer Balance – Operation & Calibration

Standard Operating Procedure for Operating, Calibrating and Cleaning of Moisture Analyzer Balance used to determine the moisture content in bulk or granulated material during manufacturing of drug product. Moisture Analyzer Balance 1.0   Objective : To lay down the procedure for cleaning, operation and calibration of Moisture Analyzer Balance. 2.0   Scope : This SOP is applicable in Manufacturing Area for cleaning,…

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Auto Coater – Operation & Cleaning Procedure

Standard Operating Procedure for Operation and Cleaning of Auto Coater - Automatic Coating Machine used for Tablet Coating during manufacturing of pharmaceutical solid dosages form. Auto Coater - Automatic Coating Machine 1.0   Objective : To lay down the procedure for cleaning and operation of Auto Coater- Automatic Coating Machine.        2.0   Scope : This SOP is applicable in Tablet Manufacturing Area …

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Rapid Mixer Granulator (RMG) – Operation & Cleaning

SStandard Operating Procedure (SOP) and Guideline for Operation and Cleaning of Rapid Mixer Granulator (RMG) used in granulation section of Oral solid dosage form at pharmaceuticals drug manufacturing plant. Rapid Mixer Granulator (RMG) 1.0   Objective : To lay down the procedure for cleaning and operation of Rapid Mixer Granulator (RMG).  2.0   Scope : This SOP is applicable in Granulation area…

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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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Cleaning Validation (CV) Procedure and Protocol

Standard Operating Procedure (SOP) and Guideline for performing Cleaning Validation (CV) of drug product manufacturing equipments. Cleaning Validation (CV) 1.0   Objective : To lay down the procedure for Cleaning Validation (CV) of manufacturing equipments. This Guideline describes the validation of cleaning procedures (CV) for the removal of contaminants associated with the previous products, residues of cleaning agents as well as…

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Deviation (Planned and Un-planned) Control System

Standard Operating Procedure (SOP) for identification, Investigation, approval, and trending of Deviation (s) which may occur during manufacturing, packaging, or any other operation/activity. Deviation Control Management 1.0   Objective : To lay down a procedure for identification, Investigation, approval, and trending of Deviation (s) which may occur during manufacturing, packaging or any other operation / activity. This SOP defines key system…

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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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