Pharma Knowledge Park
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PHARMA KNOWLEDGE PARK

Pharma Knowledge Park is exclusively designed for the pharmaceutical professionals.

This site contains links to various pharmaceutical Regulatory Sites,  Technical articles and News on updated regulatory guidelines.  This site carrying wide range of information about pharmaceutical quality requirements under one roof.

 

Actual interpretation of the GMP requirements for API : APIC revises the - How to do document on ICH Q7


APIC published final guidance on Handling of insoluble matter and foreign particle in API


USFDA published Draft Guideline on Quality Metrics


EDQM revised the guideline - Content of the dossierfor chemical purity and microbiological quality


EDQM released new edition of Tehnical Guide for the elaboration of monographs


USFDA released the final guidance on Analytical procedures and methods validation for drugs and biologics

USFDA relased the final guidance on Size, Shape and other physical attributes of generic Tablets and Capsules


WHO technical Report TRS 992 (49th Report - 2015)


WHO working document on GMP for HVAC for non-sterile pharmaceutical dosage forms


WHO working document on Good data and record management practices


Q3 (R6) - Impurities : Guideline for residual solvents - Step 2b (EMA)


EMA draft guidance on Manufacture of finished dosage form


GMP - Data Integrity - MHRA

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Concept of Quality Managerment - I (IIT)

 

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OMCL Guidelines

Qualification of Equipment - Core document*

Qualification of Equipment Annex 1: Qualification of HPLC Equipment*

Qualification of Equipment Annex 5: Qualification of Automatic Titrators*

Qualification of Equipment Annex 7: Qualification of mass spectrometers

Qualification of Equipment Annex 8: Qualification of balances
 

Visit OMCL guideline page : Click here





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