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Preparing for an Inspection or Accreditation Survey – Part 2

National Association of Boards of Pharmacy

Then, walk through each step of the practice of pharmacy such as data entry; drug utilization review; compounding; final association between the drug, the prescription, and the label (eg, the dispensing act); and patient counseling.

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What are the elements of quality control process in pharmaceuticals

GMPSOP

– Record or capture all generated raw data directly, promptly, and legibly. – Use traceable data sheets or sequentially numbered notebooks. – Date and sign or initial data entries on the day of entry. – Archive records so that they are protected, secured, and easily retrievable.

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How to perform operational qualification – step by step

GMPSOP

The data entry and retrieval process, user access and security, electronic signature, audit trail, system integration, performance, printing, etc. – Gas Chromatography (GC) Systems (Critical for analyzing volatile compounds). 90% to 110% of the label claim). Also, it can be integrated with other external interfaces.

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Typical GMP documentation in a quality control laboratory

GMPSOP

There are also forms, logs, and registers to keep track of all the little details, as well as product specifications, analytical methods, manufacturing formulae, calculation of raw data and more. Sometime these are labelled as the “hidden factory”. The significance of well-designed GMP documentations is immense.