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Medicinal gases guidance
Version 2.0, January 2019
Personnel (Chapter 2)
Senior management responsibilities for personnel
Particular emphasis is placed on the roles and responsibilities of senior management who have ultimate control over manufacturing facilities and activities in new clauses of PE009-13 (including clause 2.1 & 2.4). Senior management are accountable for ensuring appropriate resources are available to support the relevant manufacturing activities.
Necessary qualifications for staff and consultants
'Necessary qualifications' 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 (clause 2.1).
Similar records should be available for consultants used for the manufacture of medicinal gases stating the name, address, qualifications, and type of service provided by these consultants (clause 2.23).
Expectations for training and language
All personnel are to be aware of the principles of Good Manufacturing Practice that affect them and receive initial and continuing training, including hygiene instructions, relevant to their needs.
Relevant training information can be found in the PIC/S guide to GMP Part 1 clause 2.10 to 2.14.
Define and document procedures for all training requirements, including initial and ongoing training.
Generate and keep training records for all staff trained.
Ensure any person conducting training and assessment is appropriately:
- experienced in the subject matter
Provide and record appropriate training and assessment to:
- all people affected by significant change in the PQS, for example, when SOPs or equipment changes
- people who have a direct bearing on quality outcomes, including:
- senior management
- casual employees
Manufacturers are to:
- define language requirements or standards
- ensure personnel are proficient in the required language for their allocated tasks, particularly for documenting and recording tasks
- document procedures to overcome identifiable language deficiencies
Manufacturers are responsible for ensuring that the health and hygiene practices of the operators involved in manufacture do not affect the quality of the gases manufactured.
Every person entering the manufacturing areas is expected to (clauses 2.18 & 2.19):
- wear personal protective equipment appropriate to the operations to be carried out
- be prohibited, in production and storage areas, from:
- eating, drinking, chewing or smoking
- storing food, drink, smoking materials or personal medication
- drinking water in closed containers is permissible
Due to the nature of manufacturing operations, and the minimal risk to product quality, a number of clauses in Chapter 2 of the PIC/S Guide to GMP pertaining to personnel hygiene are not applicable to the manufacture of medicinal gases:
- Personal hygiene, clauses: 2.15, 2.17, 2.20 & 2.22