The Indian Pharmacopoeia Commission has released a guidance document on Good Documentation Practices (GDP). The document intends 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.
The guidance includes general requirements for GMP documentation, laboratory records, data collection and recording, data reviewing and reporting, rectification of errors/handling of missed entries and types of other GMP documents.
The document emphasised that personnel should be kept up to date about the application of good documentation practices (GDP) to ensure that the principles of ALCOA and ALCOA-plus are understood and applied to electronic data in the same manner that has historically been applied to paper records. Good documentation requirements for manual and electronic records include ALCOA: a commonly-used acronym that all records and data should be attributable, legible, contemporaneous, original and accurate; and ALCOA-plus: a commonly-used acronym for “attributable, legible, contemporaneous, original and accurate” data, which puts additional emphasis on the attributes of being complete, consistent, enduring and available – implicit basic ALCOA principles.
Regarding laboratory records, 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. Further, 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. All error rectifications/filling of missed entries should be traceable to the person who made the entry, irrespective of the stage at which the error has been noticed.
Apart from it, it said that readings should be transcribed from system to documents. Processing of chromatograms in chromatographic analysis should be done within 24 hours of completion of analysis sample set, with exception allowed in case of holiday. “If the concerned analyst is unable to attend duty on the next working day, the task should be allocated to another analyst for processing of the chromatogram. However, in any rare case after processing of chromatogram, the printout is not being taken within 24 hours, it may be taken within the next 24 hours after approval and proper reasoning,” said the document.
For data reviewing and reporting, the guidance mentioned that a single person should not sign for multiple roles for the same activity or entry. e.g. a doer cannot be the ‘Verifier’ / ‘Reviewer’ / ‘Approver’ for the same activity or entry recorded. No employee is authorised to sign for an activity performed by another employee.