Benefits of PIC/S Membership for Regulators and Industry
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Benefits of PIC/S Membership for Regulators and Industry

ByBob

On 1 January 2021, ANVISA, Brazil became the 54th member of PIC/S. Like all other PIC/S members, both ANVISA and Brazil’s pharmaceutical industry will realize a wide range of benefits of PIC/S membership, particularly at this time of the Covid-19 pandemic when on-site GMP inspections of local and foreign sites have been curtailed substantially. The…

PIC/S GMPs vs WHO GMPs – what’s the difference?
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PIC/S GMPs vs WHO GMPs – what’s the difference?

ByPharmOut

t]As many are aware, the Pharmaceutical Inspection Co-operation Scheme (PIC/S) develops and provides standards and guidelines for the harmonisation of Good Manufacturing Practice(GMP) in the global pharmaceutical industry. Those who fall under the umbrella of participating countries, often take for granted the fact that PIC/S is the go-to for compliance (i.e. Part 1, Part 2…

Serialisation Requirements in the Pharmaceutical Industry
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Serialisation Requirements in the Pharmaceutical Industry

ByWarna

Serialisation labelling requirements (serialization) for pharmaceutical products can improve patient safety, prevent counterfeit products from entering the market, and enable more efficient recalls. Why is serialisation on labelling so important? Supply chains for pharmaceutical manufacturing and medical device production are becoming increasingly complex. Medications move from production (manufacturing source) to shelf (consumers/patients). These supply chains…

Pre-use Post Sterilisation Integrity Testing – PUPSIT
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Pre-use Post Sterilisation Integrity Testing – PUPSIT

ByRichard

What is Pre-use Post Sterilisation Integrity Testing (PUPSIT)? PUPSIT stands for pre-use post sterilisation integrity testing. PUPSIT is performed once your sterilising filter is installed to ensure that the sterilisation and installation process has not damaged your sterilisation filter prior to filtration of your product. What do the regulations say? PUPSIT was first introduced to…

Good Documentation Practices (GDocP) | GMP Basics
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Good Documentation Practices (GDocP) | GMP Basics

ByConnie

GMP Basics of Good Documentation Practices (GDocP) Good documentation practice (GDocP) is a crucial component of regulatory compliance, including data integrity assurances. Referred to in the industry as Good Recordkeeping Practice (GRK), the term good documentation practice generally involves adhering to ALCOA+ principles. GRK/GDocP is mandatory to ensure that your documentation — and your products…