Manufacturing Plant Master File
A Plant Master File (sometimes referred to as a Site Master File) is a detailed description of the manufacturing facility, equipment and procedures used to produce the end-use product. It should contain sufficient information to give the reader a good idea of what the facility looks like, the type of manufacturing processes carried out in it and the type of quality assurance processes in place. It should satisfy the reader that the facility does comply with GMP requirements.
To meet APVMA requirements, the Plant Master File is expected to cover end-use product manufacture only. It does not need to cover raw materials manufacture.
The main information it should contain is described below. The important thing is to keep the document brief and relative to the needs of the type of product being made. Where possible, checklists, simple plans, outline drawings or schematic layouts should be used instead of narrative. Where a description of procedures is required, a copy of the relevant Standard Operating Procedures (SOPs) would meet APVMA requirements in most cases. As the main purpose of the Plant Master File is to demonstrate compliance with GMP, care should be taken to provide accurate and detailed information that relates to current practice in the facility.
The amount of information provided should be relevant to the type of product being made; for example, much more detailed information would be required for a facility making sterile products than for one making premixes or probiotics.
The document must be presented in English.
The Plant Master File should firstly contain:
- A brief overview of the facility, including a description of its size and nature of construction, the number of staff, the amount and type of products made there, and the company's quality policy
- The manufacturing facility:
- Floor plan, nature of construction, (ie type of building, is it open or closed construction, type of walls), air quality and type of air filtration system if relevant.
- Method of cleaning relevant to the type of product, pest control program (if relevant).
- Details of any other manufacturing activity carried out on site.
- Good quality photographs can be used to illustrate features, where appropriate.
- Storage facilities:
- Brief description of the storage facility.
- Procedures and facilities for quarantining incoming products (both raw materials and finished product) until approved for release.
- Procedures for quarantining and disposal of reject material.
- QA procedures for releasing both raw materials and finished product from storage and quarantine.
- Description of cleaning and general hygiene procedures.
- Evidence of documented cleaning procedures, eg a copy of an SOP for cleaning.
- Personnel issues:
- Qualifications/experience of production manager and QC manager (who should preferably be different people) except in the case of a very small (eg one person) operation.
- Staff training needs and what is done to address them.
- Personal hygiene and protective clothing needs relative to needs of the product and what is done to address them.
- Process water:
- Quality required and steps taken to ensure that water quality meets those requirements.
- If the required standard is water drawn from the domestic water supply, then that should be stated in the specification for process water.
- Type of testing required if relevant, how often, evidence that it is done.
- Type of equipment used.
- What steps are taken to ensure that it is correctly installed, regularly calibrated, maintained and adequately cleaned.
- Details of cleaning procedures and checks carried out on cleaning procedures to ensure that they are adequate if different products are made in the same equipment.
- Details of procedures for making sure there is no cross contamination from other parts of the facility.
- Confirmation that written specifications for raw materials, intermediates and finished products as well as packaging materials exist (these should be consistent with registration specifications).
- Examples of specifications should be provided (eg for representative raw materials and final product).
- Production procedures:
In addition the document should provide brief descriptions of:
- Procedures for checking that raw materials meet specifications.
- Details of the production procedure; packaging and labeling procedures.
- Description of in-process quality checks (eg for unwanted micro-organisms such as wild yeasts, moulds and bacteria) and quality tests on the finished product.
- Documented release procedures to ensure that finished product is not released until results of all required tests are available and have been checked against release specifications.
- Description of batch records kept which cover the process from starting materials to finished products.
- If different products are made in the same equipment, procedures for ensuring there is no cross-contamination from the previous product of the product being made.
- Providing copies of relevant SOPs is probably the best way to deal with this.
- Evidence of a discrete quality control function that is separate from production and marketing.
- Evidence that it is being implemented correctly.
- Documented change control procedures.
- Ability to conduct required quality control checks.
More detailed guidelines on the preparation of Plant Master Files may be found on the PIC/s website.
Good Manufacturing Practice
- Manufacture of veterinary chemicals
Phone: +61 2 6210 4899
Fax: +61 2 6210 4741