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Head of Production (external)

Head of Production on an interim or part-time basis: duties under § 12 AMWHV

Under § 12 and § 13 AMWHV, the Head of Production is responsible for ensuring that your medicinal products are manufactured and stored correctly, and confirms every batch in the batch manufacturing record. If the post is vacant or still to be established, A&O Pharma fills it on an interim or part-time basis at your site, integrated into your quality management system.

Arrange an initial consultation How we work with you

§ 12

AMWHV sets out the duties of the head

§ 13(8)

AMWHV: signature on the batch manufacturing record

People in our team holding this position

Key points at a glance

Legal basis checked against the statutory text, as of October 2026

Manufacturers holding an authorisation under § 13 AMG appoint a Head of Production as key personnel, as required by Chapter 2.5 of Part I of the EU GMP Guide.
The Head of Production approves the manufacturing instructions, oversees premises, equipment and maintenance, ensures validation and training, and confirms every batch with date and signature.
A&O Pharma provides an experienced person on an interim or part-time basis who works at your site, is integrated into your quality management system and appears in your job descriptions and organisation chart.

On site

Who is responsible for what.

Production and quality control work independently of each other and each sign their own record. Only on this basis does the Qualified Person release the batch.

This role Head of Production § 13 AMWHV Batch manufacturing record

Head of Quality Control § 14 AMWHV Test record

Qualified Person § 14 AMG, § 16 AMWHV Batch release

Simplified, based on Sections 12 to 16 AMWHV

At A&O Pharma

How we work with you.

Until the post is filled

Bridging a vacancy or absence

Your Head of Production is leaving, on long-term sick leave or on parental leave. We take on the role until the post is filled again, so that batch manufacturing records continue to be signed properly.

New authorisation, new premises

Setting up a site

You are applying for a manufacturing authorisation or establishing a new site. We take on the role during the set-up phase, draw up the manufacturing instructions with you and support qualification and validation until your own team is in place.

Scaled to need, with justification

Part-time for smaller operations

Where production volumes are small, the role does not fill a full position. The EU GMP Guide states that key posts should normally be occupied by full-time personnel (Chapter 2.5). Your authority decides whether a part-time arrangement is sufficient; we prepare the justification with you.

Process

How we get started.

Initial conversation

You tell us about your site, your products and the reason for your enquiry. We reply within 1 to 2 days and tell you plainly whether, and to what extent, we can take on the role.
Contract, job description and organisation chart

The duties are laid down in writing, as § 12(1) AMWHV requires. The job description and organisation chart are updated in line with § 4(2) AMWHV and approved under your internal procedures.
Integration into your operations

The person works to your SOPs, is introduced to your processes and is clearly separated from the Head of Quality Control. § 20 AMG requires notification of changes to the particulars listed in § 14(1) AMG, such as the Qualified Person; the Head of Production is no longer named there. We agree with you how your authority is to be involved.
Start and handover

After the induction period the person takes on responsibility, including signing the batch manufacturing record. When the assignment ends, we hand over to your new head in a documented manner.

Arrange an initial consultation

What the law requires

Who needs a Head of Production

Under Chapter 2.5 of Part I of the EU GMP Guide, senior management appoints key personnel, including the head of Production and the head of Quality Control. In Germany the role is governed by the AMWHV: § 2 No. 8 defines the term and § 12(1) sets out the duties. According to Chapter 2.5, key posts should normally be occupied by full-time personnel.

Duties under § 12 AMWHV

The duties must be laid down in writing or electronically. They include in particular:

ensuring that products are manufactured and stored correctly
approving the manufacturing instructions under § 13(1) AMWHV and ensuring that they are followed
overseeing the maintenance, premises and equipment used for manufacturing
ensuring that the necessary validations of manufacturing processes are carried out
ensuring the initial and continuing training of manufacturing personnel

With the exception of release, manufacturing operations are carried out under the responsibility of the Head of Production (§ 13(1) AMWHV). The Head of Production confirms with date and signature in the batch manufacturing record that the batch was manufactured in accordance with the manufacturing instructions (§ 13(8) AMWHV). Release is not permitted unless the batch manufacturing record has been properly signed (§ 16(2) No. 1 AMWHV).

Independence and relationship to the Qualified Person

The heads of Production and Quality Control must be independent from each other (§ 12(1) AMWHV, EU GMP Guide Chapter 2.5). The same person therefore cannot hold both roles. The Head of Production may, however, also be the Qualified Person: Chapter 2.5 requires a separate Qualified Person only where the heads do not themselves carry out the duties under Article 51 of Directive 2001/83/EC. Releasing each batch remains the task of the Qualified Person under § 14 AMG (§ 16(1) AMWHV).

Qualification

Unlike the Qualified Person under § 15 AMG, § 4 and § 12 AMWHV do not prescribe a specific degree for the Head of Production. § 4(1) AMWHV requires competent and adequately qualified personnel who are deployed only in line with their training and knowledge. Chapter 2.1 of the EU GMP Guide calls for the necessary qualifications and practical experience.

Organisation at your site

For staff in managerial or responsible positions, § 4(2) AMWHV requires:

job descriptions setting out their duties
an organisation chart showing the reporting lines
no gaps or unexplained overlaps between areas of responsibility
sufficient authority to carry out their responsibilities

Under Chapter 2.3 of the EU GMP Guide, duties may be delegated to designated deputies of a satisfactory qualification level.

Named individually

Who holds this role at A&O.

You know who is responsible for you before the contract starts and can reach that person directly. Cover comes from the same team.

Alexander Trautmann Head of Manufacturing GMP Consulting and Training

Dr. Thomas Lutz Qualified Person (QP) under § 14 AMG Qualified Person (QP) and Head of Production

Case studies

How we have solved this before.

All cases

Mid-sized company. Marketing authorisation holder and pharmaceutical entrepreneur

Qualified Person (QP) and Head of Production provided

A marketing authorisation holder needed a Qualified Person (QP) for batch release and, at times, a Head of Production. We provided both, and business operations continued...

Read case

Weighing it up

External via A&O or hire your own?

	External via A&O Pharma	Hire your own person
Start	No recruitment process; starts once contract and induction are in place	Advertising, selection and notice periods determine the start
Scope	Interim or part-time; your authority decides whether part-time is sufficient	Normally full-time, as Chapter 2.5 of the EU GMP Guide provides
Knowledge of your site	Induction into products, premises and SOPs is required	Builds up over time and stays in-house
Integration	Included in job descriptions, organisation chart and quality system like your own head	Part of your organisation from the outset
Duration	Bridging or set-up, with a planned handover to your own head	Permanent solution

Frequently asked questions

What we are often asked.

What does a Head of Production do?

Under § 12(1) AMWHV, the Head of Production ensures that medicinal products are manufactured and stored correctly. The role covers approving the manufacturing instructions, overseeing maintenance, premises and equipment, and ensuring process validation and staff training. The Head of Production confirms every batch with date and signature in the batch manufacturing record (§ 13(8) AMWHV).

Can the Head of Production also be the Qualified Person?

Yes. Chapter 2.5 of the EU GMP Guide requires a separate Qualified Person only where the heads do not themselves carry out the duties under Article 51 of Directive 2001/83/EC. The same person may not, however, also head Quality Control, because the two heads must be independent from each other (§ 12(1) AMWHV).

What qualifications does a Head of Production need?

§ 4 and § 12 AMWHV do not prescribe a specific degree. They require competent and adequately qualified personnel (§ 4(1) AMWHV) with the necessary qualifications and practical experience (EU GMP Guide Chapter 2.1). Your authority assesses whether the qualification is adequate for your products. If the same person is also to act as Qualified Person, the requirements of § 15 AMG apply in addition.

Is the Head of Production still regulated in the AMG?

Not expressly. § 14(1) No. 2 AMG, which used to name the Head of Production, has been repealed. § 2 No. 8 AMWHV still refers to that provision, but the duties are now set out in § 12 AMWHV and in Chapter 2 of the EU GMP Guide.

Can the Head of Production post be filled part-time or by an outside provider?

The EU GMP Guide states that key posts should normally be occupied by full-time personnel (Chapter 2.5). Your authority decides in each case whether a part-time arrangement is sufficient. What matters is that the person is integrated into your operations and quality system, appears in the job description and organisation chart and has sufficient authority (§ 4(2) AMWHV). That is how we work.

Who deputises for the Head of Production during an absence?

Under Chapter 2.3 of the EU GMP Guide, duties may be delegated to designated deputies of a satisfactory qualification level. The deputy arrangement should be set out in the job description so that there are no gaps between areas of responsibility (§ 4(2) AMWHV). For longer absences we take on the role on an interim basis.

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