1. Pink Sheet
  2. >>Compliance
  3. >>Manufacturing

PIC/S Interprets Checklist For Auditing Drug GMP Inspectorates

 
• By Bowman Cox

What makes a strong pharmaceutical inspectorate? It starts with some very specific legislative requirements that apply globally, inspectorate association explains.

Inspector removing a white card with Inspector sign from the inner pocket of his jacket. Conceptual of health, business or other inspection coming over unannounced.
the power of the inspector

The Pharmaceutical Inspection Cooperation Scheme recently published an interpretation guide for the common audit checklist used by PIC/S, the EU and Canada to assess regulatory authorities’ good manufacturing practices compliance programs.

PIC/S uses the checklist in qualifying regulatory authorities for membership. Health Canada uses it to evaluate authorities for mutual recognition...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Manufacturing

‘Why We Would Do It Again’ – Gilead & Roche On Pioneering Global Initiative For Manufacturing Change

Gilead and Roche reflect on their experiences with a global initiative that delivered aligned regulatory decisions through joint hybrid inspections and synchronized review of post-approval changes.

FY 2025 Generic Drugs By The Numbers

 
• By Derrick Gingery

New FDA data shows a potentially concerning drop in ANDA submissions, while the first-cycle approval rate increased.

US FDA ANDA Priority Pilot ‘Practically Unusable’ Without Tweaks, AAM CEO Says

 
• By Sarah Karlin-Smith

Association for Accessible Medicines CEO John Murphy told the Pink Sheet that the FDA may need to consider phasing in the requirements for the new ANDA priority voucher incentive program if it wants sponsors to apply in the near-term.

New GMP Reliance Approach In Argentina Could Save Time For Companies

 
• By Francesca Bruce

New rules in Argentina mean that good manufacturing practices certificates for foreign drug manufacturing plants issued by certain regulatory authorities could lead to quicker GMP certification evaluations.

More from Compliance

Oz: CMS Developing Plans To Incentivize Domestic Manufacturing

 
• By Sarah Karlin-Smith

The Trump Administration’s efforts to encourage more US-based pharmaceutical manufacturing have largely centered on FDA plans and Trump’s threats of tariffs and Most Favored Nation pricing, but Oz hinted Medicare and Medicaid soon may soon announce new incentives.

New GMP Reliance Approach In Argentina Could Save Time For Companies

 
• By Francesca Bruce

New rules in Argentina mean that good manufacturing practices certificates for foreign drug manufacturing plants issued by certain regulatory authorities could lead to quicker GMP certification evaluations.

Pink Sheet Podcast: US FDA Cuts Biosimilar Requirements, Clarifies Inspection Reform

 
• By Derrick Gingery, Sue Sutter, and Nielsen Hobbs

Pink Sheet editors discuss FDA announcements that clinical efficacy studies would no longer be required for biosimilar development, as well as the additional information from the agency on the intent of its “Simple Reform” of the inspection staff.