PIC/S Annex 1 Guidance and Cleanroom Project Discussions

A pharmaceutical cleanroom project brings purchasing, engineering, production and quality teams together. Each may refer to Annex 1 while asking different questions. Purchasing needs a defined supply scope, engineering needs site information, and quality needs an agreed basis for compliance. Recent guidance provides useful context, but a project still needs specific requirements that everyone can review and track.

Understand the role of the document

PIC/S PI 058-1 took effect on 28 October 2026. It uses questions and answers to explain important changes in the 2022 Annex 1, focusing on the interpretation and application of existing GMP requirements.[S2][S3] Project teams can use it to identify questions for joint discussion between quality and engineering.

Confirm the basis for a Hong Kong project

As checked on 5 November 2026, the Hong Kong Pharmacy and Poisons Board's GMP guide page for licensed pharmaceutical manufacturers lists PE 009-17 with effect from 1 July 2025.[S4] An international publication date and the applicable basis for a local project should be checked separately. Ask the project quality lead to identify the documents, versions and requirements being used before turning them into purchasing instructions.

Map the process before discussing equipment

To prepare the project brief, mark the routes for personnel, materials, tools and waste on a layout. Explain where unpacking, temporary storage, cleaning and handover occur. For a proposed pass box, describe packaging, operation on both sides and frequency of transfer as well as the required size. These details help the supplier understand the equipment's place in the process.

Separate the supply scope from the handover records

List the equipment, control functions, installation conditions and requested drawings, instructions or test records separately. Identify who will supply each item and how it will be reviewed. Record equipment function checks and process validation as separate activities, with an owner, schedule and deliverables for each. This makes the scope easier to price and coordinate.

Keep a record of changes and open decisions

For refurbishment work, assemble current photographs, layouts, existing equipment details and the operations that cannot be interrupted. List the intended improvements and update the brief after each discussion. Give unresolved items a named contact and retain the date and version of each decision. This provides a practical record when a change affects purchasing, installation or the way the space will be used.

Discuss the equipment and site requirements

Send the project purpose, drawings, equipment list and technical requirements to info@hop-yuen.com to discuss supply and configuration with Hop Yuen Industrial. Identify the project contacts for quality, engineering and validation so everyone can work from the same requirements document.

Related pages: Pharmaceutical and biotech applications