Batch Release by the Qualified Person: Evidence in Operations

The Qualified Person is responsible for each individual batch

A finished product batch can result from many work steps at several sites. Before it can be released, all relevant evidence must be consistent, from the materials used through manufacture and testing to final packaging. EU GMP Annex 16 distinguishes between the review of the batch, its certification by a Qualified Person, and the subsequent transfer to saleable stock. ^[1]

In Germany, § 19 AMG sets out the responsibility of the Qualified Person and requires certification in a continuously maintained register or a comparable document. §§ 14 and 15 AMG govern the QP’s position in connection with the manufacturing authorization and the required expertise. A QP training course alone does not satisfy this requirement. ^[2]

This article covers routine batches of authorized medicinal products for human use in Germany and the EU. Special product types and import scenarios require additional consideration.

Material release and QP certification apply to different things

For RM-427, the first decision concerns a starting material. Under EU GMP Chapter 2, section 2.8(i), the tasks of the head of Quality Control include approving or rejecting starting materials. Section 2.6, by contrast, describes the duties of the QP for batches of medicinal products. ^[3]

Approval of the starting material therefore does not certify any batch of medicinal product later manufactured from it. Likewise, an entry reading “released” is ambiguous unless it states what was released and what kind of decision was made. The workflow therefore describes material status, QP decision, and inventory status separately.

QP confirmation for a specific stage of manufacture or testing is a further, separate matter. Annex 16, sections 1.4.1–1.4.3, describe how several QPs with defined areas of responsibility can work together. The confirmation must make clear which activities it covers. In the batch documentation, it must not be treated as certification of the entire finished product batch. ^[1]

The release review covers more than final test results

§ 16(1) and (2) AMWHV ties release to a defined procedure. In addition to signed manufacturing and testing records, other essential information, the specifications including final packaging, and the reference to the marketing authorization must be taken into account. The QP retains overall personal responsibility even when relying on confirmations from other Qualified Persons. ^[4]

Preparing for release means assigning the materials actually used, the applicable instructions, results, and deviation assessments to the specific finished product batch. Contradictions between the material assignment and the batch manufacturing record must be resolved. A ticked checkbox is no substitute for what the evidence actually shows.

If a link is missing, the follow-up question must be specific: Which evidence is missing, who provides it, and which conclusion depends on it?

EU GMP Chapter 1, section 1.4(xv), requires certification before sale or supply; section 1.5 leaves responsibility for an effective pharmaceutical quality system with senior management. The QP therefore works within an organized system with defined responsibilities. ^[5]

RM-427 moves forward only after a sound material decision

In the fictitious case, the seal on container 3 of RM-427 is damaged; the physical cause remains open. Use of the material is considered only after a justified material decision and is not assumed to have taken place already. Clarifying the SOP and the change from V3 to V4 do not decide whether the material can be used; the V3 snapshot is preserved.

If the material is used later, batch traceability connects the containers actually used with the finished product batch. Ruling out an impact, or using only certain containers, also requires this link to the material. The incoming finding and its assessment remain available for the QP review.

The batch assessment depends on the current status of the investigation

For a potentially relevant finding, deviation management brings together the potential impact on material and batches and the investigation results. Root cause analysis explains which conclusions are supported and which questions remain open. For RM-427, the procedural finding must not be taken as evidence that the material quality is acceptable.

Annex 16, section 1.7.16, requires investigations to be sufficiently advanced to support certification. Section 3 concerns unexpected deviations from the manufacturing process or analytical control methods under narrow conditions: registered specifications met, thorough investigation, root cause corrected, and impact assessed as negligible. It does not give general permission to disregard material damage or an OOS result. ^[1]

An ongoing CAPA and a pending material assessment must therefore be handled differently. The status of the improvement work does not replace the assessment of the specific impact on the batch. Any open points that prevent a decision are recorded together with an expert justification.

An external Qualified Person must be properly integrated

When engaging an external Qualified Person, what counts is whether that person can actually perform the role in the intended area of responsibility. The engagement must fit the product, the procedures, the authorization, and the time available. A service agreement alone does not establish who actually performs the role or how that person receives the necessary information.

A form published by the HLfGP Hessen on external Qualified Persons lists sufficient time commitment, active integration into the quality system, training, access to records, authority, and professional independence. Where a service provider is engaged, it requires, among other things, assignment to a specific natural person. This is an example from one authority in the German state of Hesse; the specific arrangement must be agreed with the competent supervisory authority. ^[6]

This translates into practical questions to settle before the collaboration starts: Who provides the complete batch documentation? How do new findings reach the QP? Who clarifies follow-up questions and records the answers in the case? How is a suitable deputy arranged in case of absence? The flow of information must also work under time pressure.

A handover states the product, batch, scope of tasks, and open points. Additional material assessments remain linked to the same case and may require the batch to be reassessed.

§ 16(6) and (7) AMWHV governs deputizing by a qualified substitute in the event of short-term absence and the provision of the necessary resources. Where manufacturing steps take place at different sites, confirmations and divisions of responsibility must be organized so that their scope remains clear. ^[4]

Certification and status change remain traceable steps

After the assessment, the QP certification is documented for the specific batch. The subsequent transfer to saleable stock must refer unambiguously to the certification. Annex 16, sections 4.1–4.3, require safeguards against premature transfer; § 17(1) AMWHV ties placing on the market to release under § 16. ^{[1] [4]}

In the example, the handover therefore identifies the finished product batch and the associated decision. The material status of RM-427 cannot serve as a substitute. If the required decision is missing or it is unclear which batch it applies to, the handover is clarified before the stock is treated as saleable.

If the final status step is carried out at another site, the notification must reach that site unambiguously and be clearly linked to the correct batch. The site carrying out the step needs a reliable basis for doing so. A prepared shipping task or a scheduled delivery date is not a certification.

420+ connects the basis for decisions with actual execution

The operational twin connects tasks, material references, and execution records in the process context. An electronic batch record brings the batch-related information together. For RM-427, the path from the incoming finding to any later use remains traceable, without treating the material decision as equivalent to the decision on the finished product.

An audit trail preserves the context of documented changes. Change control connects the new work instruction with its introduction. The earlier execution and the later improvement thus each have their own evidence.

Roles, independent second-person review, deadlines, and escalation are configurable defaults. The expert assessment and the QP responsibility assigned by law remain with the responsible persons. The benefit lies in having a connected basis for decisions; how certification and stock transfer are integrated in detail is defined in the organization’s procedure.

Frequently asked questions about the Qualified Person and batch release

Who can become a Qualified Person?

Anyone who meets the education and practical experience requirements under § 15 AMG and demonstrates the required expertise to the competent authority; details are given in the box on required expertise.

Is a material release already a QP certification?

No. The material decision concerns a starting material and its use. QP certification concerns the specific finished product batch with its manufacturing and testing records.

Is a passing final test result sufficient?

The decision also requires other essential information, including manufacturing conditions, in-process controls, specifications, and the reference to the marketing authorization. The final test result is one part of this basis.

Can an external QP take on the role?

The specific arrangement must meet legal and regulatory requirements. Key factors include expertise, availability, authority, product knowledge, and access to the information needed for decisions.

Does a completed CAPA replace the batch assessment?

No. The CAPA improves the process. Whether the specific batch meets the conditions for certification requires its own assessment and certification.