SOP for Defining Pharmaceutical Job Responsibilities

In short: This illustrative SOP helps pharmaceutical sites define each role’s duties, authority, reporting lines and training needs. The department lists are examples to adapt; approval, testing and batch-release authority must match the applicable legal framework and the site’s approved quality system.

1. Purpose and scope

Use this template to create or maintain written job descriptions and a clear organisational structure for personnel whose work can affect pharmaceutical quality. Adapt it to the site’s activities, size, legal responsibilities and quality-system documents.

2. Regulatory context

EU GMP Part I Chapter 2, “Personnel” (revision dated 16 August 2013; effective 16 February 2014, with a minor correction in March 2014), says that responsibilities for people in responsible positions should be recorded in written job descriptions, supported by adequate authority, and arranged without gaps or unexplained overlaps. It describes general duties for Production and Quality Control heads and notes that some responsibilities may be shared with a separate Quality Assurance or Quality Unit head according to the organisation’s size and structure.

For US drug products subject to 21 CFR Part 211, §211.22 assigns the Quality Control Unit authority over specified approvals and rejections, record review and procedures; it also requires the unit’s responsibilities and procedures to be written and followed. Section 211.25 addresses education, training and experience for personnel, continuing cGMP training and adequate staffing. Apply these provisions within their regulatory scope; do not use this example as a universal organisation chart.

3. Example role allocation

Example in-house criterion (not a pharmacopoeial requirement): the department and task assignments below are illustrative. Assign each duty, authority and deputy through approved site job descriptions and procedures.

Warehouse

• Follow approved instructions for receipt, identification, quarantine, storage, handling and issue of materials and products.
• Maintain the assigned inventory and storage records and report discrepancies, damage or excursions through the applicable procedure.
• Keep storage areas in the condition defined by approved procedures and report deviations.

Production

• Work to approved production instructions and complete production records at the required stages.
• Ensure records are reviewed and signed by authorised personnel; report and document deviations under the site’s procedures.
• Coordinate assigned cleaning, maintenance, validation, qualification and training activities with the responsible functions.

EU GMP Part I Chapter 2 §2.7 lists general responsibilities of the Production head, including ensuring that products are made and stored to the appropriate documentation, production records are evaluated and signed by an authorised person, and department premises, equipment, validation and training are managed appropriately.

Engineering and maintenance

• Maintain the procedures and records assigned for equipment, utilities, preventive maintenance, breakdowns and calibration.
• Assess proposed equipment or utility changes through the site’s change-control process and support qualification activities assigned by the approved protocols.

These are example assignments; the local organisation should state which function owns each system and decision.

Quality Control

• Perform assigned sampling, testing, review and reporting under approved specifications, methods and procedures.
• Maintain the laboratory records and report out-of-specification results, deviations and other quality concerns through the applicable investigation process.
• Maintain assigned laboratory standards, reagents, media, equipment and stability-study activities under approved procedures.

EU GMP Part I Chapter 2 §2.8 describes general duties of the Quality Control head, including decisions on starting and packaging materials and products, oversight of testing and records, and approval of specifications, sampling instructions, test methods and other QC procedures. Where US cGMP applies, use the authority and written procedures required by 21 CFR 211.22; do not assume that a separate QA department replaces the defined Quality Control Unit.

Quality Assurance or Quality Unit

• Assign oversight and review responsibilities for the pharmaceutical quality system, controlled documents, changes, deviations, investigations, audits and product-quality activities.
• Define interfaces with Production, QC and the authorised batch-certification or release function. Avoid assigning every approval to “QA” by default.

Under EU GMP Part I Chapter 2 §§2.5–2.9, the responsibilities of Production, QC and (where established) QA or the Quality Unit may include both separate and shared duties. For EU batches, the Qualified Person’s certification role is described separately in §2.6. Under US cGMP, the Quality Control Unit has the authorities specified in 21 CFR 211.22.

Human Resources and department heads

• Coordinate recruitment and training records according to the local quality and personnel systems.
• Department heads identify the qualifications and practical experience needed for assigned duties, ensure staff understand their responsibilities, and arrange training before independent performance of assigned tasks.

EU GMP Part I Chapter 2 §§2.1, 2.3 and 2.10–2.11 address qualified personnel, written responsibilities, initial and continuing training and training records. 21 CFR 211.25 sets personnel training and qualification requirements for covered US operations.

See also:

• SOP for training employees
• Job responsibilities of the QC head and Quality Unit
• Responsibilities of Quality Control

4. Preparing and maintaining job descriptions

For each position, the approved description should identify:

• position title, department, supervisor and reporting relationships;
• purpose of the role and assigned duties;
• decisions the role may make, required approvals and escalation routes;
• interfaces with other functions and any formally appointed deputy;
• required qualifications, experience and role-specific training; and
• records or controlled procedures the role is responsible for completing, reviewing or maintaining.

Review the document when responsibilities, organisational structure, processes or applicable requirements change. Make sure related procedures and training records remain consistent with the approved description. The review trigger is a local document-control practice; the cited guidance does not establish a single review frequency for all job descriptions.

5. Records and retention

Maintain approved job descriptions, the organisational chart, delegation records and training evidence in the site’s controlled system. Use the applicable records schedule for personnel documents. Retain GMP records associated with a product batch for at least 1 year after the expiry date of that respective batch. EU GMP Part I Chapter 4 §4.11 requires batch documentation to be kept 1 year after expiry or at least 5 years after Qualified Person certification, whichever is longer; retain longer when local law or the marketing authorisation requires it. 21 CFR 211.180(a) sets at least 1 year after expiry for covered production, control or distribution records specifically associated with a drug-product batch.

Frequently asked questions

Does this SOP require one fixed organisation chart for every pharmaceutical site?

No. The role examples need to be adapted to the site’s activities and applicable requirements. EU GMP Chapter 2 recognises that organisation size and structure affect whether some functions are separate or shared.

Should QA always release every batch?

Do not assign batch certification or release universally to QA. EU GMP assigns a distinct Qualified Person certification role, while 21 CFR 211.22 gives the US Quality Control Unit defined approval and rejection authority. Write the applicable responsibilities into the site’s approved procedures.

How should duties be delegated?

State delegated tasks, the deputy’s qualifications and the authority attached to the work in the controlled job description or related procedure. EU GMP Chapter 2 says responsibilities should be clear and recorded, with adequate authority and no unexplained gaps or overlaps.

How long are batch-related GMP records retained?

At least 1 year after the respective product batch expires. If EU GMP applies, keep batch documentation for 1 year after expiry or 5 years after Qualified Person certification, whichever is longer; retain longer when local law or the marketing authorisation requires it.

References

• European Commission. EudraLex Volume 4, Part I, Chapter 2, “Personnel,” revision dated 16 August 2013; effective 16 February 2014, minor correction March 2014. Official Chapter 2 PDF.
• United States Government. 21 CFR §211.22, “Responsibilities of quality control unit,” current eCFR text accessed 19 October 2026. eCFR.
• United States Government. 21 CFR §211.25, “Personnel qualifications,” current eCFR text accessed 19 October 2026. eCFR.
• European Commission. EudraLex Volume 4, Part I, Chapter 4, “Documentation,” §4.11, January 2011. Official Chapter 4 PDF.
• United States Government. 21 CFR §211.180(a), “General requirements,” current eCFR text accessed 19 October 2026. eCFR.