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    • List of SOP for Pharmaceutical Quality Assurance
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Supporting Clean Areas & Clean Areas Separation in Aseptic Product Manufacturing – USFDA

March 5, 2021 Admin Leave a comment

Supporting Clean Areas Supporting clean areas can have various classifications and functions.  Many support areas function as zones in which…

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Posted in: Aseptic Processing Guidelines Filed under: Aseptic Product Manufacturing, Clean Areas Separation, Supporting Clean Areas, USFDA

Sterile Product Building, Facility and Clean Area Classification Guideline By USFDA

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Sterile Product Building, Facility and  Clean Area Classification Guideline By USFDA has clearly mentioned what conditions to be followed to…

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Posted in: Aseptic Processing Guidelines Filed under: Aseptic Processing Guidelines, Clean Area Classification, Microbiology, Sterile Conditions

TEST FOR SPECIFIED MICRO-ORGANISMS (Ph. Eur. method 2.6.13.)

March 4, 2021 Admin Leave a comment

TEST FOR SPECIFIED MICRO-ORGANISMS (Ph. Eur. method 2.6.13.) INTRODUCTION The tests described hereafter will allow determination of the absence or…

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Posted in: Microbiology Filed under: Ph Eur 2.6.13

SOP For Operation, Maintenance And Calibration Of Ultrasonic Water Bath

February 6, 2021 Admin Leave a comment

The purpose of this Standard Operating Procedure (SOP) is to lay down the procedure for Operation, maintenance and Calibration of…

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Posted in: Quality Control Filed under: Calibration, Maintenance, Operation, Quality Control SOP, Ultrasonic Water Bath

Sterile Drug Products Produced by Aseptic Processing – USFDA Guideline for Buildings & Facilities

January 22, 2021 Admin Leave a comment

21 CFR 211.42(b) states, in part, that “The flow of components, drug product containers, closures, labeling, in-process materials, and drug…

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Posted in: USFDA Guidelines Filed under: Aseptic Processing, Buildings & Facilities Guidelines, Sterile Drug Products, USFDA Guidelines

EU Guidelines For Computerized System Part- 2

January 19, 2021 Admin Leave a comment

Project Phase Validation4.1 The validation documentation and reports should cover the relevant steps of the life cycle. Manufacturers should be…

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Posted in: Quality Assurance Filed under: Computerized System, EU Guidelines

EU Guidelines For Computerized System Part -1

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PrincipleThis annex applies to all forms of computerised systems used as part of a GMP regulated activities. A computerised system…

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Posted in: Quality Assurance Filed under: Computerized System, EU Guidelines

Manufacture of Liquids, Creams and Ointments

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PrincipleLiquids, creams and ointments may be particularly susceptible to microbial and othercontamination during manufacture. Therefore special measures must be taken…

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Posted in: Production Filed under: Creams and Ointments, Guideline, Manufacture of Liquids

Sampling on Starting and Packaging Materials

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PrincipleSampling is an important operation in which only a small fraction of a batch is taken. Valid conclusions on the…

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Posted in: Packaging Filed under: Packaging Materials, Quality Assurance, Sampling

EU Guideline For Outsourced Activities

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EU Guidelines For Outsourced Activities Any activity covered by the GMP Guide that is outsourced should be appropriately defined, agreed…

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Posted in: Quality Assurance Filed under: Chapter 7, EU Guideline For Outsourced Activities, EUDraLex Volume -4

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  • SOP List For Pharmaceutical Quality Assurance
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  • WHO

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Analyst Qualification Audit Preparation Calibration CAPA Change Management System Cleaning Validation Compression Machine Computerized System EU Audit Requirements FDA Warning Letter HPLC Calibration ICH Guideline ICH Q10 laboratory guideline MHRA Microbial Testing Microbiology Microbiology SOP Microbiology Techniques OOS Operation Out of Specification Out of Trend Pharmaceutical Production Pharmaceutical Quality System Phase-I Phase-II Phase Ia Phase Ib production Production SOP QMS Qualifications Protocol Qualification  Steps Quality Assurance Quality Control Quality Control Laboratory Quality Control SOP Quality Management System SOP SOP for Qualification of Quality Control analyst Stability Study Sterile Pharmaceutical products Sterility Testing USFDA
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