ICH Q7 (Section 16 – CONTRACT MANUFACTURER (INCLUDING LABORATORIES) Defines: “There should be a written and approved contract or formal agreement between a company and its contractors detailing the GMP responsibilities, including quality measures, of each party”. Only in case you miss it above will the control laboratory have to generate complete data, as GMP requests for all the work it seems to be doing. This includes both the paper and electronic records I mentioned in a previous “Focus on Quality” section (10). The FDA guidelines specify that the quality agreement must document how the “immediate recovery” requirement is met by either the owner or the contract laboratory (1). Both types of datasets must be protected and managed during the retention period. To simplify, the objective of a quality agreement is to manage the expectations of both parties concerned from the point of view of the quality of work and compliance with the rules in force. Under the FDA, there is no explicit regulation in 21 CFR 211 (8), but it is a regulatory expectation, as discussed in the guide (1). Note that a quality agreement does not exempt the contractor (usually a pharmaceutical company) from responsibility and responsibility for the work performed. A control laboratory should be seen as an extension of its own facilities.
On the other side of the Atlantic, the European Union (EU) published a new version of Chapter 7 of the GMP (Good Manufacturing Practices) regulation, which entered into force on 31 January 2013 (2). This document has been updated due to the need for a revision of the guidelines on outsourcing activities regulated by PMGs (3) in the light of the International Conference on Harmonization (ICH) Q10 on Pharmaceutical Quality Systems (3). The title of the chapter has been changed from “contract manufacturing and analysis” to “outsourced activities” in order to give the regulation a broader scope, especially in the context of the globalization of the pharmaceutical industry these days. You may also recall a previous column `Focus on Quality` (4), which deals with Annex 11 of the EU-GMP on computerised systems (5), according to which agreements were needed with suppliers, consultants and contractors for services. These agreements required clear information on the level of performance and a definition of the responsibilities of all parties. At the end of section 3.1, it was also found that IT services are analog (5) – oh! As the great analytical chemist Ronald Reagan said: “trust, but check” (this is the English translation of a Russian proverb). The audit is used before a quality agreement and confirms that the laboratory can perform the work with an appropriate quality system. Then, when the analysis is in progress, the audit confirms that the work is being performed according to the required standards.
Both the FDA and the EU require the owner or tunder to examine the agencies to which it entrusts the work. In any case, the communication process between the laboratory and the owner must be defined for routine, escalation and emergency cases. How will the communication be carried out? Choices can be phone, fax, scanned documents, email, online access to laboratory systems or all of the above. However, it is not good to define communication processes, because they are managed by people, so it is necessary to appoint analysts, SAQ (QA) employees and their assistants on both sides and understand their roles and responsibilities. The most recent Community guidelines, Chapter 7, have been revised taking into account the ICH Q10 pharmaceutical quality system. It adds that “any activity covered by the outsourced GMP Guide should be defined, agreed and controlled in an appropriate manner in order to avoid any misunderstanding that could result in an unsatisfactory quality product or process. . . .