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GMP Standard Operating Procedures (SOPs)

WEBWriting Standard Operating Procedure. Standard Operating Procedures (SOPs) are issued to specifically instruct employees in areas of responsibility, Work Instructions, …

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URL: https://www.gmpsop.com/site-overview/gmp-standard-operating-procedures-sops/

GMP rules to keep pharmaceutical warehouse in perfect condition

WEBGMP rules for the warehouse enable manufacturers to: – Protect medicines from damage during storage and transport. – Prevent degradation of the product by …

Category: Medicine Go Health

Annex 3 Guidelines on Good Manufacturing Practices for

WEB29 sanitized. Adequate precautions should be taken to avoid contamina-tion of the drainage system with radioactive efﬂuents. 4.4 Lighting, heating, ventilation and, if necessary, air …

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Understanding of International GMP Regulatory Requirements

WEBIf this monitoring turns up a problem that needs to be corrected, the regulatory authority can, 1.) Ask the manufacturer to recall the product, 2.) Withdraw approval (of a …

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Annex 4 Supplementary guidelines on good manufacturing …

WEBAn authorized written procedure giving instructions for performing opera-tions not necessarily specifi c to a given product or material but of a more general nature (e.g. …

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Deviation Reporting Guidelines in GMP Facilities

WEBDeviation investigation is a mandated requirement for pharmaceutical production process. Deviations to approved Production, Testing, or Distribution …

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EHS-130 Environmental Health and Safety Risk Assessment …

WEBIn a GMP environment a risk-based approach has to be used to evaluate the hazards and controls used to mitigate them. Hence it is essential for Risk assessments to be …

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Department Environmental, Health and Safety Document no …

WEB2.0 PURPOSE. The purpose of this document is to define the first-aid procedure for the GMP site. The first-aid procedure shall encompass the responsibilities and actions …

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Guidance 129 – Labeling of APIs and API Intermediates

WEBThe recommendations and requirements presented in this document are based upon Quality Standards and guidance documents published by the World Health Organization …

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EHS-100 Personal Protective Equipment (PPE) Policy for a GMP

WEBFind it here! Update Account Profile. 240 SOPs, 197 GMP Manuals, 64 Templates, 30 Training modules, 167 Forms. Additional documents included each month. All written …

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Worldwide Regulatory References

WEBGood Manufacturing Practices and Requirements of Premises, Plant and Equipment for Pharmaceutical Products Schedule M. Worldwide Regulatory References. Regulations …

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EHS-065 Hot Work Permit Procedure

WEB5.1. Initiation of Hot Work Permit 5.1.1 Prior to commencement of any hot work, the Engineering or Facilities representative must be contacted to obtain a blank Hot Work …

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Market Actions Policy at a GMP Site

WEBMarket Action Procedure shall be available at each GMP site that produces, stores or distributes Drug Products, Active Pharmaceutical Ingredients (API) or Medical …

Category: Medical Go Health

Good Practice Quality Systems Management Samples

WEBDeviations to approved Production, Testing, or Distribution Procedures for Active Pharmaceutical Ingredients (API), Drug Products, Medical Devices, Consumer Health …

Category: Medical Go Health

Record Keeping and Record Management Practice in GMP

WEBAuditors review records to ensure they are accurate and complete and follow GMP. They place importance on this review when forming opinions on company …

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Annex 7 Application of Hazard Analysis and Critical Control …

WEB103 Some stages are linked to speciﬁc principles while others serve as an introduction to the concept. The seven principles are: 1. Conduct a hazard analysis.

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Environmental Health and Safety Risk Management

WEBThe purpose of this SOP is to: Describe the risk management process of identifying EHS hazards, assessing risk, designing appropriate controls and reviewing the controls. …

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Health Products and Food Branch Inspectorate

WEBHealth Canada / Health Products and Food Branch Inspectorate Good Manufacturing Practices (GMP) Guidelines – 2009 Edition, Version 2 (GUI-0001) / March 4, 2011 Page …

Category: Food Go Health

Manual 058 Out of Specification Results Investigation

WEB2 Scope and Applicability. This Guideline applies whenever a laboratory test result is out of specification. It may apply to any laboratory, its joint ventures and licensees who operate …

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