Supplier qualification is a general system for the assessment of suppliers and service providers.
Qualification is required for suppliers of starting materials and packaging materials, intermediate and finished products (contract manufacturers) and, in the broader sense, for manufacturers of machines, equipment, spare parts, computer systems, utilities and aids.
An important goal of supplier qualification is to ensure supply chain dependability. Supplier qualification also aims to ensure that the quality of materials and services is reliably maintained.
Supplier qualification is required in almost all GMP-relevant regulations.
For starting materials and packaging materials, general requirements for the supply chain designed to reduce risks to medicinal product quality and safety are described. For active substances and excipients, special requirements must also be considered.
The lifecycle of the supplier relationship passes through the phases of planning and selection, risk assessment, qualification and approval, supply and monitoring, periodic evaluation and requalification. The scope and depth depend on the risk relevance. (Christian Gausepohl, PhD)
Audits are an absolute MUST for every pharmaceutical company. In this chapter you will learn what audits are for, which occasions and types of audits there are, which principles and regulations apply. (Stephanie Blum, PhD)
Audits must be planned! But WHO needs to be audited and HOW OFTEN? The answer is – as so often – a risk-based approach. However, the best audit planning is of no use without contractual agreements on rights and obligations. (Stephanie Blum, PhD)
An audit is only as good as the way in which it is prepared! But how do you set the right priorities and where do you get the necessary information? In this chapter you will find all the important questions on audit preparation and get useful tips for the first contact with the auditee and the preparation of the audit agenda. In addition to the preparation of the content, organisational aspects are also discussed. (Stephanie Blum, PhD)
In this chapter, all steps of an audit are explained, from the opening meeting, through the walk-through and the documentation check, to the final feedback meeting. What information is obtained where, and how can the observations best be recorded, collated and evaluated? Ultimately, the audit findings are of the greatest importance for both parties. They must be formulated clearly and comprehensibly and may also contain recommendations by the auditor regarding the necessary corrective measures. (Stephanie Blum, PhD)
The auditor's work does not end with the final feedback meeting: now it is time to prepare the audit report, evaluate the action plan and meet the required deadlines. The next step is to follow up on the planned measures. Only when all measures have been successfully implemented is the audit officially concluded. (Stephanie Blum, PhD)
Auditing has to be learned! An auditor must have the necessary professional competence, but also methodological competence and social competence. But even if all these prerequisites are met, one does not become a good auditor overnight – only practice and gaining experience can help here. And the principle of "together we are strong" also applies to auditing: multiple auditors can naturally accomplish more than just one – and a thoughfully selected team maximises expertise. (Stephanie Blum, PhD)
Audits of contract manufacturers and contract laboratories are part of daily business for many auditors. But what if you have to audit suppliers of active ingredients and excipients, manufacturers of packaging materials, collectors of medicinal plants or service providers who are not involved in GxP? In this chapter you will learn how you can familiarise yourself with the respective special features in advance and what you should pay attention to when auditing. (Stephanie Blum, PhD)
Why not just let someone else do the work for you? What sounds like the subject line of a dubious spam e-mail is a serious and often sensible option for audits. Especially for small and medium-sized pharmaceutical manufacturers, the extensive audit obligations are a real challenge. Third-party audits – audits delegated to specialized audit service providers – are a sensible and high-quality alternative.
Work sharing is also possible: Shared audits refer to audits carried out jointly by several pharmaceutical manufacturers at one auditee. The advantages of these audits are time savings for the auditee and synergies on the part of the auditors. Both types of audits can be easily combined. (Stephanie Blum, PhD)
Directive 2001/83/EC has been editorially updated. All further relating official Directives and Regulations are now directly accessible through links embedded in the document.
Following a meeting of the European Medicines Regulatory Network, EMRN, about preventing nitrosamine impurities, EMA has updated its Q&A document, accordingly. Modifications in the response templates that should be used to address no identified risk/identified risk and no nitrosamine detected/nitrosamine detected, resulted in adjustments to the questions 3, 4, 5 and 8.
The revision of the FDA nitrosamine guidance details the recommended timeframe for API manufacturers for a risk assessment of nitrosamine impurities. It says:
“Confirmatory testing should start as soon as the risk of nitrosamine is identified from the risk assessment and should begin immediately for products considered at high risk. To ensure the safety of the U.S. drug supply, confirmatory testing of drug products and submission of required changes in drug applications should be concluded within 3 years of publication of the original guidance, with a recommended completion date of on or before October 1, 2023.”
Unlike the European Q&A paper on the subject, US manufacturers do not need to submit risk assessment documents to the agency, but they should retain these documents to be available if requested.
PIC/S has updated the following four Aide-Mémoires, which became effective on 1 January 2021:
Please note that the changes involve solely the cross-references to the PIC/S GMP Guide.