IPC Releases Guidance Document On Good Documentation Practices


Mumbai : The Indian Pharmacopoeia Commission (IPC) has released a guidance document on Good Documentation Practices (GDP).

The guidance document is intended to provide general guidance to all users of the IP to help in ensuring proper compliance with the IP requirements when standards of drugs are to be determined.

Good documentation practices are those measures that collectively and individually ensure documentation, whether paper or electronic, is secure, attributable, legible, traceable, permanent, contemporaneously recorded, original, and accurate.

This document covers different levels and types of good manufacturing practice (GMP) documentation, including paper and electronic records related to manufacturing, testing, packing of pharmaceutical products, APIs, excipients, dietary supplements, food ingredients and medical devices.

The document said that all technical activities should be carried out with valid, correct and currently effective versions of instruction documents and recording formats should have an identification number and a version number (where appropriate), allowing the sufficient space to record entries, etc for laboratory records.

The document further stated that signing for an activity in advance or post-dating (back dating that is, signing for an activity with a back-date) either documents or corrections should be strictly prohibited.

For data collection and recording, good data and records management practices are critical elements of the quality system and a systematic approach should be implemented to provide a high level of assurance that throughout the product life cycle, all GMP records and data are complete and reliable, the document said.

Laboratory information management system(s) (LIMS) includes the management of data and information contained in both computerized and non-computerized systems should be well defined in quality standard procedures.

The computerized laboratory information management system used for the collection, processing, reporting, storage, retrieval of data should be validated for functionality before introduction and any subsequent changes should be validated before implementation.

The document said, “For data reviewing and reporting, specimen signatures, initials record of each employee involved in GMP documentation should be maintained to use for traceability of signatures for all the records. Signatures essentially mean that the signatory is responsible for the accuracy of data and information for the activity being signed for. Hence, the signatory should confirm the accuracy and completeness of information and data before signing.”


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