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The value of India’s retail pharmaceutical market is estimated to touch $59 billion by the fiscal year 2023, which presents a promising opportunity for retail pharmacies to bolster and strengthen their operations. These systems have helped pharmacists efficiently manage their operations, enabling them to generate more revenue.
AEs can be caused by using medicinal products within or outside the terms of their marketing authorisations (such as off-label therapeutic use, overdose, misuse, abuse or medication errors), as well as from occupational exposure. The following is adapted from a presentation given by Dave Par é and Silvio Scozzari at the DIA 2022 conference.
We will present the rationale behind the qualification decision and reference that with the GAMP (Good Automated Manufacturing Practice) categories in support of the decision you will make. The dataentry and retrieval process, user access and security, electronic signature, audit trail, system integration, performance, printing, etc.
– Record or capture all generated raw data directly, promptly, and legibly. – Use traceable data sheets or sequentially numbered notebooks. – Date and sign or initial dataentries on the day of entry. – Archive records so that they are protected, secured, and easily retrievable.
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”. – Ensure systems for archiving of electronic data or notebooks are present.
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