Tag Archives: Repton

Review of Batch Manufacturing Record

Review of Batch Manufacturing Record Objective: To lay down a procedure for the review of batch manufacturing records.  Scope: This Standard Operating Procedure is applicable for formulation plants of a Pharma company. Responsibility: Officer / Executive, Quality Assurance shall be responsible for reviewing Batch Manufacturing Record. Head – Quality Assurance …

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In-process Controls in Tablet Compression and Capsule filling

In-process Controls in Tablet Compression and Capsule filling Objective: To lay down a procedure for conducting Inprocess Controls during Tablet Compression and Capsule Filling. Scope: This standard operating procedure is applicable to the formulation plant of a Pharmaceutical company. Responsibility: The production Executive / Officer shall be responsible for the …

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Entry and Exit for Executives, Staff, Visitors in Production Area (gowning and degowning procedure).

Objective :To lay down a procedure for Entry and Exit for Executives, Staff, Visitors in Production Area (gowning and degowning procedure). Scope :This standard operating procedure is applicable for the entry and exit in Production Block of Pharmaceutical company. Responsibility: Executive / Staff / Visitors entering in production area shall …

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Basic Requirement of Documentation and Records for GMP Compliance

Documentation and Records for GMP Compliance GOOD MANUFACTURING PRACTICES GMP is that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use. GMP is aimed primarily at diminishing the risk inherent in any pharmaceutical production. Such risks are …

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COMPRESSION MACHINE URS (USER REQUIREMENT SPECIFICATION)

COMPRESSION MACHINE URS (USER REQUIREMENT SPECIFICATION) Table of Contents of compression machine URS General Salient Features Operational Requirements Utilities Maintenance Inspection and Testing Commissioning and Documentation Training Packaging Deviations Delivery TECHNICAL REQUIREMENT OF COMPRESSION MACHINE URS Equipment No. : To be embossed/imprinted conspicuously on the equipment Description:  37-station double rotary compression machine, …

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Engineering Question & Answer

Engineering Question & Answer 1.Question:What is the good engineering practice (GEP) Answer:  good engineering practice (GEP) means to established engineering methods and standards that are applied throughout the project life-cycle to deliver appropriate, cost-effective solutions.   2.Question: How can defined the validation ? Answer:  The documented act of proving that any procedure, process, equipment, material, …

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SOP on New Product Design and Development Process

SOP on New Product Design and Development Process The objective of the New Product Design and Development Process : To lay down a Procedure for New Product Design and Development Process. Scope : This Standard Operating Procedure is applicable all pharmaceutical formulation plants of Pharmaceutical Companies. Responsibility Head, Clinical Research: …

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SOP On In-process Control of Packing Line

SOP On In-process Control of Packing Line OBJECTIVE : To ensure quality of Finished Products during strip packing and final packing operation of tablets. SCOPE: This SOP shall be applicable in-process controls during primary and secondary packing operation of tablets. RESPONSIBILITY :  In process Quality Assurance Officer / Executive shall …

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SOP on Sampling of Intermediates and Finished Products

SOP on Sampling of Intermediates and Finished Products OBJECTIVE : To lay down a procedure for sampling of intermediate(blend/core/coated/capsules) and finished products (packing)during manufacturing operations. SCOPE: This SOP shall be applicable to the IPQA in Quality Assurance Department. RESPONSIBILITY:  In process Quality Assurance Executive/Officer shall be responsible for follow the …

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SOP On In-process Control During tablets Manufacturing

SOP On In-process Control During Tablets Manufacturing OBJECTIVE:  To lay down the procedure for In process Controls during Tablet Manufacturing. SCOPE : This SOP shall be applicable for in process controls during tablets manufacturing of pharmaceutical company. RESPONSIBILITY: Production /Quality Assurance Executive/Officer shall Be responsible for follow the procedure mentioned …

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Operating Procedure for Incinerator

Objective :To lay down a procedure for Operation of Incinerator. Scope :This Standard Operating Procedure is applicable for the formulation plant of pharmaceutical company.   Responsibility: Concerned Technician/Operator shall be responsible for operating the Incinerator as per this SOP. Officer/ Executive- Engineering shall be responsible for the implementation of this SOP. Accountability:Head …

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Procedure for Analysis of Treated Effluent

Objective:To lay down a Laboratory procedure for the analysis of Treated Effluent. Scope:This standard operating procedure is applicable for formulation plant of pharmaceutical company. Responsibility: ETP chemist shall be responsible for testing of Treated Effluent. COD :  Chemical Oxygen Demand D.O :Dissolved Oxygen FAS : Ferrous Ammonium Sulfate BOD : Biochemical …

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Cleaning of filters for Dispensing Booth

Objective:To lay down a procedure for Cleaning of filters for Dispensing Booth. Scope:This Standard Operating Procedure is applicable to the formulation plant of pharmaceutical company. Responsibility The Concerned Technician shall follow the Cleaning Procedure as per this SOP. The Officer/Executive-Engineering shall be responsible for implementation of this procedure as per …

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Preventive Maintenance of Purified Water (Generation and Distribution) System

Objective:To lay down a procedure for Preventive Maintenance of Purified Water System (Generation and Distribution). Scope:This Standard Operating Procedure is applicable for formulation plant of pharmaceutical company. Responsibility The Concerned Technician shall follow the procedure for Preventive Maintenance as per this SOP. The Officer/Executive-Engineering shall be responsible for implementation of …

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Colour Coding system of Utility Lines

Objective:To lay down the Colour Coding system for indicating the contents of Utility Lines. Scope: This Standard Operating Procedure is applicable to the formulation plant of pharmaceutical Company. Responsibility The Concerned Technician shall follow the Colour Coding System as per this SOP. The Officer/Executive-Engineering shall be responsible for implementation of the …

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preventive maintenance

Objective:To lay down a procedure for preparing preventive maintenance procedures or programs for equipment or system and their component(s). Scope:This standard operating procedure is applicable for preparation of Preventive Maintenance procedure or programs for all equipments or systems installed in the formulation plant. Responsibility Officer/ Executive- Engineering shall be responsible …

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Calibration of Equipment and Instruments from External Authorized Agencies / Suppliers

Objective:To lay down a procedure for Calibration of equipments and instruments from external authorized Agencies / Supplier. Scope:This procedure shall be applicable for calibration of equipment / instrument of all the departments of pharmaceutical Company Responsibility Head of Engineering: (i) For maintaining records (ii) For the selection of authorized calibration …

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Sanitization of Purified Water Generation and Distribution System

Objective:To lay down a procedure for Sanitization of Purified Water Generation and Distribution system. Scope:This Standard Operating Procedure is applicable to the formulation plant of pharmaceutical Company. Responsibility The Concerned Technician shall follow the Sanitization Procedure as per this SOP. The Officer/Executive-Engineering shall be responsible for implementation of the procedure …

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Operating Procedure for Purified Water Distribution System

Objective:To lay down an Operating Procedure for Purified Water Distribution System. Scope:This Standard Operating Procedure is applicable to the formulation plant of pharmaceutical Company(Make- Neela Metal,Capacity- 2.5m3/hr) . Responsibility The Concerned Technician shall follow the Operating Procedure as per this SOP. The Officer/Executive-Engineering shall be responsible for implementation of the …

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