GMP Regulations in Nigeria

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When it comes to medicines, safety and quality are non-negotiable. In Nigeria, the Good Manufacturing Practice (GMP) Regulations ensure that pharmaceutical products are produced with the highest standards of quality and safety. Introduced by NAFDAC…

The CTD Unveiled: Your Guide to Quality Standards

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Welcome to our guide on the Common Technical Document (CTD) quality standards, where we make sense of the rules for pharmaceutical submissions. If you've ever felt lost in the maze of regulations, fear not! We're…

Cartons – Packaging material standard test procedure

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Folding cartons are small to medium sized cardboard boxes made from paper board.  The paperboard are cellulose derived substrate, with thickness generally greater than 200 mm which   are made from virgin and recycled fiber. They are…

Validation Master Plan – SOP

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1.0 OBJECTIVE : To provide a guideline procedure for framing the validation plan for the equipment/ instrument/ utilities/ systems/ premises/ process used for manufacturing of the drug products. 2.0 SCOPE : This procedure is applicable to…

Quality Control – Principle, General information

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Quality Control in Medicinal Products | Quality Control Principle | Quality Control General Information | Good Quality Control Laboratory Practice | Play Video Inside the Pharmaceutical Quality Control Department: Ensuring Safety and Efficacy Quality Control…

Checking personnel hygiene by dab test method-SOP

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1.0 OBJECTIVE To describe procedure for Microbial Count on Hands by using dab test method. 2.0 SCOPE It applies to the all staff and workers who are coming in direct contact with product during Manufacturing/processing.…

Operation of Micrometer Screw Gauge SOP

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1.0 OBJECTIVE : To provide a procedure for Operation of Micrometer Screw Gauge. 2.0 SCOPE : This procedure is applicable to Micrometer Screw Gauge. 3.0 RESPONSIBILITY : Quality control Chemist and above 4.0 ACCOUNTABILITY: Quality…

Preparation of Site Master File – SOP

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SOP for Site Master File | Site Master File of Pharma Company | Site Master File SOP covers below points: Site Master File General Information Site Master File include below information Personnel Premises Equipment Documentation…