Institute of Good Manufacturing Practices India
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Approved by Quality Council Of India (QCI), Government of India
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Registered under The Societies Registration Act,1860 Government of India
Empanelled under Ministry of Horticulture and Food Processing, Government of Uttar Pradesh
International Register of Certificated Auditors (IRCA) accredited Lead Auditor (FSMS) course
Affiliated with Life Sciences Sector Skills Council (SSC) and Food Industry Sector Skills Council set up by National Skill Development Corporation (NSDC)
Conferred with QUALITY COUNCIL OF INDIA (QCI) – D.L. SHAH NATIONAL QUALITY AWARD

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New Strategic Plan for 2017-2019: Issued by PIC/S

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) released the new road map for the next two years. PIC/S declared that training would be imparted to its most important field of activity i.e. revised Annex 1 on Sterile Manufacturing of the PIC/S GMP Guide corresponding to the July 2016 launch of the PIC/S Inspectorates’ Academy (PIA).

In addition, PIC/S plans to improve co-operation with the International Coalition of Medicines Regulatory Authorities (ICMRA).

The harmonisation of GM(D)P is another essential mission of the PIC/S. It is aimed at covering the areas such as:

Here is a summary of the latest PIC/S developments in GM(D)P Harmonisation:

  1. The formalised risk assessment for ascertaining the appropriate GMP for excipients of medicinal products for human use
  2. The principles of good distribution practice for active substances of medicinal products for human use
  3. Setting health based exposure limits for use in risk identification in the manufacturing of different medicinal products.
References

  1. PIC/S Press Release

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