Earlier I have shared you the GMP Requirement for Pharmaceutical plant premises, Equipment’s, Production, Training, personnel Hygiene and Self-Inspection, quality audits and suppliers’ audit. There are various modules of GMP which I will share one after another & today’s module is Personnel.
General :
For maintaining a satisfactory Quality system and control of pharmaceutical products depends upon people. For this reason there must be sufficient qualified personnel to carry out all the tasks for which the manufacturer is responsible. Individual responsibilities should be clearly defined and understood by the persons concerned and shall be recorded.
The manufacturer should have an adequate number of personnel with the necessary qualifications and practical experience.
Responsible personnel duties should be assigned based up on Experience and qualifications. The manufacturer or the company should have an organization chart.
All personnel should be aware of the principles of GMP and during joining they have to take the GMP training, personnel hygiene instruction, Good Documentation practice and Data Integrity etc. All personnel should be motivated to support the establishment and maintenance of high quality standards.
Steps should be taken to prevent unauthorized people from entering production, storage and QC areas. Personnel who do not work in these areas should not use them as a passageway.
Key Personnel :
Key personnel include the heads of production, the head(s) of quality unit(s) and the authorized person. The quality unit(s) typically comprises the quality assurance and quality control functions. In some cases, these could be combined in one department. The authorized person may also be responsible for one or more of these quality unit(s). Normally, key posts should be occupied by full-time personnel. The heads of production and quality unit(s) should be independent of each other. Key personnel responsible for supervising the production and quality unit(s) for pharmaceutical products should possess the qualifications of a scientific education and practical experience required by national legislation. Their education should include the study of an appropriate combination of: (a) chemistry (analytical or organic) or biochemistry; (b) chemical engineering; (c) microbiology; (d) pharmaceutical sciences and technology; (e) pharmacology and toxicology; (f) physiology; (g) other related sciences. They should also have adequate practical experience in the manufacture and QA of pharmaceutical products.
The heads of the production and the quality unit(s) generally have some shared, or jointly exercised, responsibilities relating to quality. These may include, depending on national regulations: (a) Authorization of written procedures and other documents (b) Monitoring and control of the manufacturing environment (c) Plant hygiene (d) Process validation and calibration of analytical apparatus (e) Training, including the application and principles of QA; (f) Designation and monitoring of storage conditions for materials and products; (g) Performance and evaluation of in-process controls; (h) Retention of records; (i) Monitoring of compliance with GMP requirements; (j) Inspection, investigation and taking of samples in order to monitor factors that may affect product quality.
Responsibilities of Head Production:
The head of production generally has the following responsibilities: (a) to ensure that products are produced and stored in accordance with the appropriate documentation in order to obtain the required quality; (b) to approve the instructions relating to production operations, including the in-process controls, and to ensure their strict implementation; (c) to ensure that the production records are evaluated and signed by a designated person; (d) to check the maintenance of the department, premises and equipment; (e) to ensure that the appropriate process validations and calibrations of control equipment are performed and recorded and the reports made available; (f) to ensure that the required initial and continuing training of production personnel is carried out and adapted according to need.
Responsibilities of Head Quality:
The head(s) of the quality unit(s) generally have the following responsibilities: (a) to approve or reject starting materials, packaging materials, and intermediate, bulk and finished products in relation to their specifications; (b) to evaluate batch records; (c) to ensure that all necessary testing is carried out; (d) to approve sampling instructions, specifications, test methods and other QC procedures; (e) to approve and monitor analyses carried out under contract; (f) to check the maintenance of the department, premises and equipment; (g) to ensure that the appropriate validations, including those of analytical procedures, and calibrations of control equipment are carried out; (h) to ensure that the required initial and continuing training of quality unit personnel is carried out and adapted according to need; (i) establishment, implementation and maintenance of the quality system; (j) supervision of the regular internal audits or self-inspections; (k) participation in external audit (vendor audit); (l) participation in validation programmes.
The authorized person is responsible for compliance with technical or regulatory requirements related to the quality of finished products and the approval of the release of the finished product for sale or supply.
Assessment of finished products should accept all relevant factors, including the production conditions, the results of in-process testing, the manufacturing (including packaging) documentation, compliance with the specification for the finished product, and an examination of the finished pack.
No batch of product is to be released for sale or supply prior to certification by the authorized person(s). In certain countries, by law, the batch release is a task of the authorized person from production together with the authorized person from QC.
The function of the approval of the release of a finished batch or a product can be delegated to a designated person with appropriate qualifications and experience who will release the product in accordance with an approved procedure. This is normally done by QA by means of batch review.
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