Describing what is the key role and responsibility of production and quality units? This helps to avoid misunderstandings between the two major departments. 

Role and Responsibility of Production unit & Quality unit

In the pharmaceutical industry, production and quality units are major departments. Both are having their own role and responsibility.

The quality unit should be independent of the production department. The quality unit includes both quality assurance (QA) and quality control (QC).

Depend on the manpower quality unit structure design. They may be in the form of separate QA and QC units or both are combined, depending upon the structure designed by the organization.

The operating system always planned, approved, conducted, and monitored for that purpose this both units are playing an important role. Production units perform all the operations from receipt of the product to the finished product.

The step involves in between receipt of product to finished product is processing, packaging, and labelling. This all operation is carried out as per defined time limit. All persons involved in manufacturing, testing, and assuring the quality is responsible for the quality of the product.

1.0 Key role & responsibilities of the Quality Unit (Quality Assurance & Quality Control)

The role and responsibility for quality units create, monitor, and implement the quality system. This role responsibilities should be described in writing, and should include but not necessarily be limited to:

1.1 All quality-related matters handled by quality unit.

1.2. Review and approve all quality-related documents.

1.3. Releasing or rejecting API, Intermediates, and finished product dosage form.

1.4. Design a system to release or reject raw materials (RM), intermediates, packing material (PM), and labeling materials.

1.5. Reviewingall critical process steps of completed batch production and laboratory control records are before the release of the API, intermediate, and finished dosage form for distribution. Below documents are review before batch release –

1.5.1.  Completed Batch production record (BPR) or Batch production and cleaning record (BPCR).

1.5.2. Completed Batch packing record (BPR).

1.5.3. All logbooks used for completion of batch production and packing record.

1.5.4. Completed analytical test protocols (Calculation sheet) used for batch testing.

1.5.5. All logbooks used for the testing batch.

1.5.6. Review for critical deviation, Out of specification (OOS).

1.6. Making sure that all critical deviations are reported by the concerned department. All of these deviations are investigatedand resolved with proper corrective and preventive action (CAPA) prior to the release of the batch.

1.7. Approving all specificationsincludes raw material, packing material, intermediate, API, finished dosage form etc. which are related to the laboratory.

1.8. Approving master batch record (MBR) instructions.

1.9. Approving all procedures (written instructions e.g Standard Operating  procedures SOPs) which impact the qualityof intermediates, APIs, and finished dosage form.

1.10. Conducting and ensure that internal audits (self-inspections) are performed which help to building the quality of intermediate, API, finished dosage form.

1.11. Approving contract manufacturers and contract laboratories for their quality purpose. Ensure that the manufacturing facility or laboratory comply cGMP before approval by conducting inspection/audit.

1.12. Approving changes that potentially impact on the quality of intermediate or API.  These changes approved by the change control procedure.

1.13 Reviewing and approving validation protocols includes process validation, cleaning validation, equipment validation, analytical method validation, gowning validation, etc. Also, review and approve the reports of validations.

1.14. Ensuring that all quality-related complaints (market complaints)  are investigated and resolved with proper corrective and preventive action (CAPA).

1.15 Ensuring that effective systems are adopted for maintaining (preventive maintenance) and calibrating critical equipment.

1.16 Ensuring that materials are appropriately tested as per the testing instruction design and the results are reported in the testing protocol.

1.17. Making sure that the stability datais available to support retest or expiry dates of intermediate, API, dosage form.

1.18 Ensure that appropriate storage conditions mention on the label of APIs,  intermediates, and dosage form.

1.19 Performing product quality reviews. Perform the review of product considering all batches manufactured in one year.

1.20 Ensure the cleaning in manufacturing (Line Clearance) performed. No traces are found while examining the cleaning and cleaning results are meet the set specification limit.

1.21 Preparing and approving Quality Manual which describes quality related aspects.

2.0 Key Responsibility of Production unit 

The role and responsibility for production activities should be described in writing  to all persons who involve in producing the API, intermediate, dosage form and should include but not necessarily be limited to –

2.1 Prepare, review, approve, and distribute the instructions for the  production of intermediates, APIs, the dosage form according to written procedures like BMR, BPR

2..2 Producing intermediate, APIs,, dosage form according to pre-approved  instructions includes batch manufacturing records (BMR), batch cleaning records, batch packing records (BPR), etc.

2.3. Reviewing all production batch recordsto ensure that these records are completed and sign/date. 

2.4 Ensure that all production deviations are reported, evaluated, and that critical deviation are investigated and the conclusions are recorded. 

2.5. Ensure that production facilities are clean and if applicable facilities are disinfected.

2.6. Ensure that the necessary calibrations are performed on measuring devices, instruments (weighing balance) and kept records of obtained results.

2.7. Ensure that the premises, facility, and equipment are maintained (preventive maintenance) and maintenance records kept.

2.8 Ensure that validation protocols (process validation and cleaning validation) and reports are reviewed and approved.

2.9. Evaluate proposed changes in product, process, equipment, facility. Initiate the change as per the change control procedure and justify the need for change.

2.10. Ensure that new and when appropriate, modify facilities and equipment are qualified.

2.11 Ensure that the equipment, the area should be clean prior to starting a new operation  (Line Clearance). No traces of previous material include raw material, packing material, samples, the batch product should be found. Extra precaution required when manufacturing operations performing in a non-dedicated (multipurpose) area.

3.0   References

3.1 ICH Q7 Good Manufacturing Practices for Active Pharmaceutical Ingredients

3.2 EU The Rules Governing Medicinal Products in the European Union Volume 4 Good Manufacturing Practice Medicinal Products for Human and Veterinary Use Part II: Basic Requirements for Active Substances used as Starting Materials

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