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PE009-13, the PIC/S guide to GMP for medicinal products
TGA interpretation and expectations for demonstrating compliance
Personnel (Chapter 2)
Senior management responsibilities for personnel
New clauses in PE009-13 (including clause 2.1) place particular emphasis on the roles and responsibilities of senior management who have ultimate control over manufacturing facilities and activities. Senior management are accountable for ensuring appropriate resources are available to support the relevant manufacturing activities.
Necessary qualifications for staff
'Necessary qualifications' in clause 2.1 means having the education, training, experience and skills, or any combination of these elements, that will ensure that staff can perform assigned duties and functions at an acceptable level.
Qualification requirements for an Authorised Person
There are no minimum qualification requirements for Authorised Persons specified within Australian legislation. However, in accordance with Good Manufacturing Practice, senior management should ensure that person(s) undertaking the role of Authorised Person have the education, training, experience and skills or any combination of these elements to ensure that they can perform the role of the Authorised Person.
In general an Authorised Person should be able to demonstrate the following competencies:
- knowledge of the requirements of Good Manufacturing Practice applicable to the dosage forms for which they are responsible
- a comprehensive understanding of the manufacturing methods and controls for the specific dosage form(s) for which they are responsible
- knowledge of the regulatory requirements relevant to the dosage forms manufactured by their site. In particular knowledge of the marketing authorisation requirements for the specific products for which they are responsible
- working knowledge of the Pharmaceutical Quality System implemented at their manufacturing site
Expectations for training and language
Training and assessment should be carried out by persons with relevant training, qualifications and experience in the subject matter (clauses 2.10 to 2.14).
Training should be given to all people affected by significant change in the Pharmaceutical Quality System, e.g. when SOPs or methods of manufacture change. The requirement for initial and ongoing training should be reflected in procedures, and training records should be generated and kept.
There are a number of people who have a direct bearing on quality outcomes. These include senior management, contractors, consultants and casual employees. Therefore, appropriate training and assessment should be provided and recorded.
Manufacturers should define language requirements or standards and ensure personnel are proficient in the required language for their allocated tasks, particularly in relation to documenting and recording. Procedures employed to overcome identifiable deficiencies should also be documented.
Role of consultants
Management of consultants
Where consultants are engaged by a manufacturer to assist in operations, it is important that adequate records are kept and maintained, these include:
- contracts between the manufacturer and consultant outlining the scope of services;
- up-to-date copies of each consultants curriculum vitae;
- job descriptions outlining roles, responsibilities, delegations and/or authorisations;
- Training records for local PQS procedures relevant to their role.
It is the responsibility of the manufacturer to assess consultants and to ensure that they have adequate education, training, and experience, or any combination thereof, relevant to the services for which they are engaged.
Approval of controlled documents
Consultants are permitted (where defined by agreements) to write, review and approve documents within the PQS; however, the licence holder ultimately remains responsible for the content of, and adherence to authorised procedures within their Pharmaceutical Quality System and cannot delegate or discharge the overall responsibility for the accuracy and content of documents signed by the consultants.