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Indian Pharmacopoeia Commission publishes compliance guide

03-Jan-2013

Related topics: QA/QC, Regulations, Regulatory & Safety

The Indian Pharmacopoeia Commission (IPC) says a first of its kind guidance manual will help drugmakers comply with quality requirements and testing procedures.

The document – which is available for INR300 ($5.41) – covers topics ranging from good laboratory practices (GLP) and monograph development to stability testing equipment testing, QA/QC and water quality regulations. 

The IPC said that: “This Guidance Manual is first of its kind for Pharmacopoeial Standards in India” and suggested it will be beneficial to both manufacturers and regulators.

This will go a long way to enable the regulatory bodies in the discharge of their duties to streamline the functions of their own laboratories and also the in-house laboratories of drug manufacturers and commercial drugs testing laboratories.”