SOP

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PERFORMANCE QUALIFICATION PROTOCOL PURIFIED WATER SYSTEM

PERFORMANCE QUALIFICATION PROTOCOL PURIFIED WATER SYSTEM OBJECTIVE To describe the Performance Qualification procedure to be used during validation of purified water system in order to: a) ensure the system reproducibility over an appropriate time period as per user requirement specifications. b) ensure that the system is showing consistency in producing …

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Cleaning Validation – Glossary of Terms

Cleaning Validation Glossary of Terms 1 Acceptable daily intake An amount of a substance administered or consumed on a daily basis that will not produce a pharmacological or toxic response 2 Analyte Substance for which an analysis is being performed 3 API Active pharmaceutical ingredient 4 Automated cleaning A cleaning …

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Production & purification of Purified water as per WHO

Production & purification of Purified water as per WHO General considerations The specifications for WPU found in compendia (e.g. pharmacopoeias) do not define the permissible water purification methods apart from for BWFI. The chosen water purification method or sequence of purification steps must be appropriate to the application in question. …

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Production & purification of drinking-water as per WHO

Production & purification of drinking-water as per WHO General considerations The specifications for WPU found in compendia (e.g. pharmacopoeias) do not define the permissible water purification methods apart from for BWFI. The chosen water purification method or sequence of purification steps must be appropriate to the application in question. The …

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General principles for pharmaceutical water systems As per WHO

General principles for pharmaceutical water systems Pharmaceutical water production, storage and distribution systems should be designed, installed, commissioned, qualified and maintained to ensure the reliable production of water of an appropriate quality. It is necessary to validate the water production process to ensure the water generated, stored and distributed is …

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Materials in Pharmaceutical as per WHO Guideline

Materials in Pharmaceutical as per WHO Guideline Principle. The main objective of a pharmaceutical plant is to produce finished products for patients’ use from a combination of materials (starting and packaging). Materials include starting materials, packaging materials, gases, solvents, process aids, reagents and labelling materials. No materials used for operations …

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SOP on SOP

SOP on SOP Objective : To lay down a procedure for the preparation, approval and control of Standard Operating Procedures. Scope: This Standard Operating Procedure is applicable for the preparation and implementation of all Standard Operating Procedures to be followed at Pharmaceutical Company. Responsibility Staff of Initiator Department shall be …

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ICH Q8/Q9/Q10 Questions and Answers

ICH Q8/Q9/Q10 1.1 For General Clarification Date of Approval Questions Answers 1.0 June 2009 Is the minimal approach accepted by regulators? Yes. The minimal approach as defined in Q8(R2) (sometimes also called ‘baseline’ or ‘traditional’ approach) is the expectation that is to be achieved for a fully acceptable submission. However, …

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Guidance Document Cleaning Validation

Guidance Document Cleaning Validation Scope Introduction Principles Validation of Cleaning Processes Equipment and Personnel Microbiological Considerations Documentation Analytical Methods Sampling, Rinsing, Rinse Samples and Detergents Establishment of Limits Change Control/revalidation References   3.1 The objective of the cleaning validation is to verify the effectiveness of the cleaning procedure for removal …

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Technology Transfer in pharmaceutical manufacturing (WHO)

Technology Transfer in pharmaceutical manufacturing (WHO) Introduction Scope Glossary Organization and management Production: transfer (processing, packaging and cleaning) Quality control: analytical method transfer Premises and equipment Documentation Qualification and validation 1.1 Transfer of processes to an alternative site occurs at some stage in the life-cycle of most products, from development, …

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Process Validation Critical Parameters

Process Validation Critical Parameters Process Validation(FDA Definition) Establishing Documented Evidence, Which provides a high degree of assurance that a specific process will  consistently produce a product meeting its predetermined specifications and quality attributes.” Steps in Validating a Process: Develop validation protocol Conduct installation qualification Conduct operational qualification Conduct performance qualification …

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Equipment Status log

Equipment Status log OBJECTIVE: To lay down a procedure of the maintenance of equipment sequential log. SCOPE: This SOP is applicable to all equipment and machines of all manufacturing departments RESPONSIBILITY: Production and Engineering officer/above shall be responsible to follow the procedure mentioned in this SOP. ACCOUNTABILITY : Concerned Department Head and QA Head …

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Cleaning of general item

Cleaning of general item OBJECTIVE: To lay down a procedure to describe the steps to be followed for cleaning general items. SCOPE: Applicable for cleaning all HDPE / SS containers, utensils, scoops, sampling tools and different cleaning aids RESPONSIBILITY: Housekeeping workers, Production Supervisors, Operators, IPQA personnel shall be responsible to follow the …

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NON-CONFORMANCE RESULTS

NON-CONFORMANCE RESULTS OBJECTIVE: To lay down the procedure for define the necessary action against the non-conformance of a product. SCOPE: This procedure is applicable for information, investigation and control for any kind of non- conformance noticed or confirmed in Production, Stores on in others area for its proper investigation RESPONSIBILITY: Officer – …

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Prevention and Product Mix Up

Prevention and Product Mix Up OBJECTIVE:   To lay down the Procedure for prevention of Product mix-up. SCOPE: This procedure is applicable for the control and prevention of product mix up during and after the manufacturing of the product . RESPONSIBILITY: QA officer and Production Officer shall be responsible for the …

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GUIDE TO INSPECTIONS VALIDATION OF CLEANING PROCESSES

INTRODUCTION To establish inspection consistency and uniformity by discussing practices that has been found acceptable (or unacceptable). The cleaning validation – to validate the process and collect the scientific data that prove the system consistently does as expected and produce a result that consistently meets predetermined specifications. This guide is …

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Non-sterile process validation

Non-sterile process validation Process validation data should be generated for all products to demonstrate the adequacy of the manufacturing process at each site of manufacture. The validation should be carried out in accordance with good manufacturing practices (GMP) and data should be held at the manufacturing location and made available …

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URS of De-Dusting Machine

URS of De-Dusting Machine S. No. Table of Contents 1.0 General 2.0 Salient Features 3.0 Operational Requirements 4.0 Utilities 5.0 Maintenance 6.0 Commissioning and Documentation 7.0 Training 8.0 Packaging 9.0 Deviations 10.0 Delivery TECHNICAL  S. No. Parameters Required Specifications 1. 1.1 General Equipment No. 1.2 Description Portable unit for Tablets …

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SOP on house keeping, cleaning and sanitization of general area in Pharmaceutical company

SOP on house keeping, cleaning and sanitization of general area in Pharmaceutical company. Objective :To lay down a procedure for Good House Keeping, cleaning and sanitization of General Area. Scope: This procedure is applicable for cleaning and sanitization of General areas other than manufacturing area of the Pharmaceutical Company. Responsibility: …

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QUALITY SYSTEMS MODEL (Resources)IN PHARMACEUTICAL INDUSTRY (Part – II)

QUALITY SYSTEMS MODEL The goal  is to describe a model for use in pharmaceutical manufacturing that can help manufacturers comply with the CGMP regulations. It should be noted that implementing an effective quality system in a manufacturing organization will require a significant investment of time and resources. However, we believe …

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