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.”