The SIDs are not affected, as the obligations of manufacturing authorisation holders in this case are set out in Directive 2005/28/EC, which does not contain corresponding requirements for active substances. In addition, this is clearly stated in the introduction to Part II of the GMP Directive. Annex 8 of the GMP Directive states that the identity of a complete batch of raw materials can generally only be guaranteed if individual samples are taken from all containers and an identity test is carried out on each sample. Only part of the containers may be sampled if a validated procedure has been established to ensure that no container of raw material has been mislabelled. However, the Annex specifies that it is unlikely that a process of raw materials intended for use in parenteral products can be satisfactorily validated. Traceability is the ability to retrieve the history of manufacturing and distribution operations of a batch of a drug. Small manufacturing devices are sometimes equipped only with microprocessors and firmware and are unable to perform high-level management functions. In addition, the data on these devices is often temporary in nature. Due to the latter, there is no risk of accidental modification of the data. Therefore, an audit trail is not required and user access may be limited to these settings control features.
The statement provided by the QP should set out in detail the basis for the statement that the standards applied offer the same level of safety as GMP. The European Medicines Agency will gain experience with this approach, which can serve as a basis for discussion on related changes to the guidelines in the future. Article 5.25 of the GMP Directive requires that raw materials come from approved suppliers of which the manufacturer has special and in-depth knowledge. Other sources should normally be sought, but in exceptional cases, the manufacturing authorisation holder should assess and document the extent to which GMP is being met and provide a risk-based justification for accepting a waiver. Batch records: These documents are usually used and completed by the manufacturing department. Batch records provide step-by-step guidance for production-related tasks and activities, as well as including areas in the batch record itself to document those tasks. The European Medicines Agency (EMA) provides answers to frequently asked questions on Good Manufacturing Practices (GMP) and Good Distribution Practices (GMP), which have been discussed and approved by the GMP/GDP Inspectors Working Group. A manufacturer`s assessment must be carried out and the application must be reviewed against the requirements of the intended use. From the perspective of the regulated industry, the implementation of such a device is controlled by an implementation lifecycle.
At the very least, the following points need to be addressed: While the rationale for a particular step is not immediately apparent, it may have been placed there as a review for another phase of the process. Ideas for improvement should always be encouraged, but do not change procedures without assessing the impact on the entire process. Think about what happens in a workplace when written procedures are not available. People rely on older employees to tell them how to do things and then do their memory work. This is fine for a company that makes garden pots, but not so good if the products manufactured are pharmaceuticals and can even lead to death! Test methods: These documents are usually used and completed by the Quality Control (QC) department. Test methods provide step-by-step instructions for testing consumables, materials, products and other production-related tasks and activities, such as environmental monitoring of the GMP facility. Good records make it possible to track all the activities carried out during batch production, from the receipt of raw materials to the final release of the product; They provide a history of the lot and its distribution. Accurate records in GMP are essential, and during an audit, it helps convey the message that procedures are being followed. It also shows that the processes are known and under control. The manufacturer must prepare a concise document in the form of a “site master file” containing specific and factual GMPs on the manufacture and/or control of pharmaceutical manufacturing processes carried out on site.
It should contain the following descriptions: after discovery, repeated deviations from the manufacturing process and/or analytical control methods should be considered as modifications and modifications of the authorisations concerned should be submitted. In exceptional circumstances to avoid interruption of delivery, it may be possible to continue QP certification while corrective and preventive measures are taken. see Q&A on the “unexpected” gap above. The EU principles and guidelines on GMP are set out in Directives 2003/94/EC (medicinal products for human use) and 91/412/EEC (veterinary medicinal products). These principles and guidelines are the subject of more detailed guidelines in the form of the EU GMP Directive with its annexes. The level immediately below the regulations, level 1 documents (e.g., the quality manual), should divide the regulations into parts specific to those that the company must follow.