Van Zyl GMP International. Dr AJ van Zyl

10/11/2025

https://theacademicnetwork.net/fda-announces-nationwide-recall-of-cholesterol-medication/

08/11/2025

https://www.linkedin.com/pulse/gmp-requirements-isolator-restricted-access-barrier-systems-shetty-u43df

Executive Summary This report provides a comparative analysis of the Good Manufacturing Practice (GMP) requirements for Aseptic Processing Isolators and Restricted Access Barrier Systems (RABS). The comparison is structured based on the criteria established by the United States Food and Drug Adminis

31/10/2025

Process validation.
Access this article by Uday Shetty on Linked In for his take on prices validation, where he compares FDA, EU and WHO guidelines on this topic.

His summary reads:

"The global regulatory landscape for process validation has decisively shifted towards a harmonized, science-driven lifecycle model. The US FDA, EU, and WHO are aligned in their core philosophy that quality must be proactively designed into a product through deep process understanding, confirmed through qualification, and maintained via continuous verification. This shared foundation, built upon ICH principles, marks a significant step forward from older, more rigid validation paradigms.

However, this philosophical convergence gives way to divergences in practical implementation. The FDA's framework is characterized by a singular, well-defined Process Performance Qualification (PPQ) pathway, creating a uniform standard for all products. In contrast, the EU offers a more flexible, multi-faceted approach, allowing manufacturers to choose between Traditional, Continuous, or Hybrid validation strategies, with submission requirements tiered based on process risk. The WHO provides a global benchmark that accommodates and validates a risk-based justification for any of these approaches. These differences are not trivial; they necessitate that manufacturers develop nuanced, market-specific validation strategies to navigate the distinct regulatory expectations and ensure compliance across all major jurisdictions".

28/10/2025

27/10/2025

Zazibona is pleased to invite pharmaceutical manufacturers across Africa to express their interest in participating in the 3rd Quality Circle Meeting on Good Manufacturing Practices (GMP), scheduled to take place in Johannesburg, South Africa, on 08-09 December 2025.
This important regional initiative aims to foster collaboration, promote knowledge sharing, and strengthen capacity in GMP standards across the continent. The meeting will bring together industry leaders, regulatory experts, and technical professionals to discuss best practices, emerging trends, and practical solutions to enhance pharmaceutical quality and safety.



Please find attached the flyer with the topics to be addressed, the cost recovery fee, and a registration link.Following your registration, the proforma invoice will be sent.

Key Details:
• Event: GMP 3rd Quality Circle Meeting
• Dates: 08-09 December 2025
• Location: Birchwood Hotel & OR Tambo Conference Centre, Johannesburg, South Africa
• Deadline for Expression of Interest: 31 October 2025



Interested organizations are encouraged to submit their Expression of Interest by the deadline to ensure consideration for participation.



Further details regarding the agenda, logistics will be shared with registered participants.



For any enquiries, please contact us at gmp@mcaz.co.zw

17/10/2025

Read more on the FDA findings at Hetero Labs Ltd, observations pertaining to the use of an off site QC laboratory, discrepancies, documents, OOS investigation and use of outside warehouse.

Learn a few lessons from these

12/10/2025

10/10/2025

Natco Pharma (India) ... Adcock Ingram South Africa

05/10/2025

The Tamil Nadu government has banned the sale of the ‘Coldrif’ cough syrup produced by the state-based Sresan Pharmaceuticals, following suspicions about the medicine causing the death of 11 children in Madhya Pradesh and Rajasthan. The state government has also ordered the removal of the medicine from the market.

According to reports, the sale of the cough syrup manufactured by the Chennai-based firm Sresan Pharmaceuticals has been prohibited across Tamil Nadu from October 1.

Sresan Pharmaceuticals’ manufacturing facility in Sunguvarchathram in Kancheepuram district was inspected and samples were collected as part of the inspection. Reports stated that the company supplies medicines to Rajasthan, Madhya Pradesh, and Puducherry.

The Union Health Ministry on Friday, October 3, issued an advisory to all states and Union Territories directing that the prescription of cough and cold medications to children below two years of age should not be allowed. The advisory was issued following the reports of deaths of children allegedly caused by contaminated cough syrups in Madhya Pradesh and Rajasthan. In Chhindwara, nine children have died since early September after allegedly consuming the cough syrup.

Sresan Pharmaceuticals’ has been reportedly asked to halt the production of the syrup. Laboratory tests conducted in Tamil Nadu confirmed the presence of Diethylene Glycol, a highly toxic industrial chemical. This prompted the Madhya Pradesh government to ban the sale of Coldrif and all the medicines manufactured by the company.

The Ministry of Health and Family Welfare said that the laboratory tests of the samples collected from Chhindwara district in Madhya Pradesh, where the child deaths were reported, detected neither Diethylene Glycol nor Ethylene Glycol. Both are industrial chemicals known to cause acute kidney injury.

Analysis of wider batches of the cough syrup is still pending. A multi-disciplinary expert team comprising representatives from the National Centre for Disease Control (NCDC), National Institute of Virology (NIV), Indian Council of Medical Research (ICMR), AIIMS Nagpur, Central Drugs Standard Control Organisation(CDSCO) and state authorities is investigating alternative causes for the deaths.