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Category: Quality Assurance

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

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

Change management system ICH – Q10

January 11, 2021 Admin Leave a comment

Change management system – Innovation, continual improvement, the outputs of process performance and product quality monitoring and CAPA drive change.…

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Posted in: Quality Assurance Filed under: Change Management System, ICHQ10

MICROBIAL CONTAMINATION OF COMPRESSED AIR

December 30, 2020 Admin Leave a comment

MICROBIAL CONTAMINATION OF COMPRESSED AIR Compressed air systems can harbor the nutrients required for microbes to grow; namely water, oil,…

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Posted in: Quality Assurance Filed under: Compression Machine, MICROBIAL CONTAMINATION

Cleaning Validation Protocol Format

October 5, 2020 Admin Leave a comment

A cleaning validation protocol format shall be developed for the ‘worst case’ product selected for cleaning validation programme. Following information…

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Posted in: Quality Assurance Filed under: Cleaning Validation, Cleaning Validation Protocol Format, Quality Assurance

SOP on Site Master File (SMF) Preparation

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Standard Operating Procedure (SOP) and Guideline for preparation, approval, and revision of Site Master File (SMF). The Site Master File…

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Posted in: Quality Assurance Filed under: Site Master File, SMF

SOP For Vendor Management

September 13, 2020 Admin Leave a comment

The manufacturer or supplier who is supplying the material in routine and registered for the supply of specific material after…

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Posted in: Quality Assurance Filed under: QMS, Quality Assurance

Annual Product Review (APQR / APR / PQR)

September 12, 2020 Admin Leave a comment

Annual Product Review (APR) is the requirement of various regulatory agencies. APR roots the monitoring of product quality as well…

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Posted in: Quality Assurance Filed under: Annual Product Review, Quality Management System

SOP for BMR & BPR Review

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Standard Operating Procedure (SOP) for Review of Batch Manufacturing Record (BMR) and Batch Packing Record (BPR) in the pharmaceutical manufacturing…

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Posted in: Quality Assurance Filed under: BMR & BPR Review, Quality Assurance, Quality Control SOP

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  • SOP List For Pharmaceutical Quality Assurance
  • SOP on Change control
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  • SOP on Training of Employees
  • 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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