What you need to know about PIC/S GMP Documentation Tips
The TGA’s announcement of its intention to adopt PIC/S GMP PE 009-13 as of 31 December 2017 means Australian GMP manufacturers need to review their current document retention schedules and practices to maintain compliance. PharmOut’s leading PIC/S GMP consultants have studied the new guidance and provides the following PIC/S GMP documentation tips.
Overview of the main changes
Sections relating to documentation and records in PIC/S PE 009-13 (Part 1) have been revised and in some cases expanded to provide clarity on a number of points, including:
- which documents to retain
- retention duration
- location of retention
- control of retained record integrity
- responsibility for retention
- quality or GMP training required.
The new guidance acknowledges that documentation can be paper-based, electronic, photographic, or ‘hybrid’ – a combination of paper-based and electronic. It uses ‘documentation’ and ‘record(s)’ interchangeably. Interestingly now, the term “typed” is the same as “written”, so trying to get everyone on the same “page”, or now “screen”.
A closer look at the changes
Chapter 4, Documentation, contains a new section called Retention of Documents and a couple of other changes. As you read through the new guidance, look out for the following:
|§4.10 (new)||Records retention systems must clearly indicate which manufacturing activity the records relate to and where the records are located. Validation may be required.|
|§4.11 (new)||Batch documentation for investigational medicinal products (i.e. clinical trial products) must be retained for at least five years after the completion or discontinuation of the trial.|
|§4.12 (new)||For the life of a product’s Market Authorisation, retain all documents (e.g. specifications, process validation records, URS, DQ, batch manufacturing and packaging records, procedures and logbooks) that support information in the Market Authorisation and support the release of batches that are still within the required retention period following release for sale or supply.|
|§4.21||Previously 4.18. Content clarified and reformatted. Added requirement for ‘approval by the person responsible for the packaging operations’ (p.23). Note added to allow for reduced documentation requirement where a validated process is continually monitored and controlled.|
|§4.31||Previously 4.28 and 4.29. Content reworded and now includes the need to record in logbooks any major or critical analytical testing.|
There are some sections outside of Chapter 4 that also deal with documentation and we should consider in the blog around PIC/S GMP Documentation tips. Keep an eye out for these points as you read through the new guidance.
Other changes relating to documentation:
|§1.8 viii||Previously 1.2 vii. There are significant changes in this section and highest area for citations by the MHRA during GMP inspections.|
|§2.9||Previously 2.7. Expanded to state that the Quality Head or Quality Assurance Manager now has mandatory shared responsibility with the heads of Production and of Quality Control for document retention, particularly with respect to how retention is designed into and handled by the QMS.|
|§2.11||In addition to on-going GMP and role-specific training, Manufacturers are now required to train staff in the Quality System and keep records of the training.|
|§2.23||Manufacturers are now required to record and retain evidence of the name, address and qualifications of any consultant they retain, and the nature of the service the consultant is to provide.|
|§6.8||Now refers to Chapter 4 for the retention period of Quality Control documents relating to batch records, rather than specifying one year beyond batch expiry.|
|§6.10||Replaces ‘record’ with ‘documentation’ and ‘original data’ with ‘raw data’ and provides an example: ‘…other raw data such as laboratory notebooks and/or records…’|
|Annex 2 §28||Requirement added to retain traceability records for 30 years after the product’s expiry date.|
|Annex 3 §33||Requirement added to retain records for at least 3 years or as otherwise specified by national requirements.|
|Annex 11 §3.1||Previously §18 and now contains more detail about what to include in written agreements with third parties engaged to provide IT-related services.|
|Annex 11 §7.1||Previously §13. Less prescriptive than before.|
|Annex 14 §9||Previously §25. Clarifies that multiple products can be derived from the same pool.|