What is Minimum Requirements of EU Agencies from Production section of Manufacturing site.?

Minimum Requirements in  Production section  for EU authorized Human Pharmaceutical products manufacturing site as per Eudralex Volume 4  part 1 Chapter 5: Production. …

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Minimum Requirements of Premises and Equipment as per EU Guideline before going for EU Regulatory Audit.

Minimum Requirements of EU for Premises and Equipment in Human Pharmaceutical products Manufacturing site  as per EU Guideline before going…

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Definitions of Pharmaceutical terms.

Definitions of Pharmaceutical terms as per WHO. The definitions given below apply to the terms used in this guide. They…

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Process Validation in Pharmaceutical Industry

Process Validation Successful  Process Validation gives assurance about produced Drug Quality . which is Drug should be fit for its…

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Good manufacturing practices for Pharmaceutical products

current Good manufacturing practices for pharmaceutical products (cGMP) As per WHO 1.1 Good manufacturing practice is that part of quality…

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SOP on Handling of Incidents and Deviations

SOP on Handling of Incidents and Deviations PROCEDURE: Definition: Departure from an approved instruction or established standard. Deviation shall be…

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Drug Regulatory Affairs – CTD

Drug Regulatory Affairs – CTD. Drug Regulatory Affairs in Pharma Industry plays important role as all departments of Pharma product…

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SOP on Maintenance and Preparation of Anaerobic Culture Suspension.

SOP on Maintenance and Preparation of Anaerobic Culture Suspension ( Clostridium Sporogenes ). This procedure is for Maintenance & preparation of culture…

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SOP on Change Control

SOP on Change control PROCEDURE: TYPES OF CHANGE CONTROL: DOCUMENT CHANGE CONTROL (DC) : Initiation of a document or modification…

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Self Inspection in Pharmaceutical Industry

Why Self Inspection is Important in Pharmaceuticals industry …?   Self inspection is mandatory by Regulatory Authorities like MHRA, EU,…

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