The audit carried out by the holder of the manufacturing authorisation should be an integral part of the manufacturer`s quality system and be subject to the essential requirements of the GMP, i.e. be carried out by duly qualified and trained personnel in accordance with the approved procedures. It should be properly documented. These aspects may be verified, if necessary, by the competent authorities. Robert Iser, Vice President of PAREXEL Consulting, spoke with Pharmaceutical Technology Europe about the role of quality agreements in outsourcing. Controls for paper datasets are explained elsewhere in this guide. Serious PG problems which may lead to an abnormal limitation of supply should be submitted to the auditor and the competent authorities, in accordance with the legal obligations set out in Article 23(2) of Directive 2001/83/EC, Article 27 of Directive 2001/82/EC, Regulation (EC) No 2001/82. Regulation (EC) No 726/2004 and the EMA1 Guidelines: a formal corporate policy document should clearly indicate which types of suppliers and services require a quality agreement. Whenever a CMO/contractor is set up, there must be a quality agreement. A quality agreement should be concluded with all suppliers of critical materials, also recommended for suppliers of large quantities, for example.

B methylcellulose for capsules, column resins, etc. The specification limit values for the biological load shall be TRL 10 CFU/100 ml, in accordance with the human and veterinary instructions for the preparation of the final submission (CPMP/QWP/486/95 and EMEA/CVMP/126/95). And in ICH Q10, 2.7, “The pharmaceutical quality system, including the management responsibility described in this section, extends to the control and verification of outsourced activities. The responsibilities of the contracting entities and the buyer in the field of quality should be defined in a written agreement. Where a manufacturer of a medicinal product receives a serious complaint about the quality of the medicinal product itself or the packaging components, the system should allow for the identification of the bottles concerned and, if necessary, the recall of the bottles concerned from the market. PTE: What is the responsibility of a pharmaceutical company to guarantee the quality and safety of products or ingredients manufactured in a contract establishment? In cases where national competent authorities have additional national expectations regarding the quality defects to be reported and the deadlines for notification, they should be respected. It should also be noted that ICH [International Council for Harmonization] Q7 (3) contains useful information on quality agreements with API production sites, supplemented by the FDA`s guidelines on quality agreements. Companies developing combination products should check the expectations contained in the guidelines on current requirements for good manufacturing practice for combination products, as they relate to contractual arrangements and quality agreements (4). For example, in the case of a batch release decision, the data that determines compliance with critical quality characteristics is more important than storage records. In cases where an alleged quality defect affects more than one production site, the reporting obligations should be laid down in a technical agreement.

It is normal to expect the recall and location of the final certification of EU batches to take the lead in reporting, unless justified. A recent example of a citation of a quality agreement in a warning letter (7) referred to a quality agreement concluded with the company`s contractual manufacturer, which did not contain provisions on the treatment of sterilisation and other provisions of the quality agreement that were not routinely complied with. While this warning letter refers to a device and follows the expectations of the purchasing controls at 21 CFR 820.50 (8), it also shows that clarity of roles and responsibilities and compliance with approved quality agreements are important aspects that must be taken into consideration when a company develops and implements a quality agreement with a contracting body. and can be evaluated while an FDA reviewer is on site….