How we design for compliance
Regulatory Design Basis
There is no single rulebook for a pharmaceutical facility. ALVEDA SOLUTIONS establishes the design basis for each project from the client’s market, product, facility type, regulatory authority and project requirements, then engineers against that agreed basis.
Inputs
What the basis is built from
Five inputs are agreed with the client before layouts are fixed. Together they decide which requirements apply and how strictly.
- 01
Market
Where the products will be sold, and therefore which authorities will inspect or accept the facility.
- 02
Product
Dosage form, sterility, potency and hazard, which drive classification, segregation and containment.
- 03
Facility type
Manufacturing plant, sterile suite, compounding pharmacy, laboratory or water system, each with its own requirements.
- 04
Regulatory authority
The national authority and any export-market authorities whose guidance the project will follow.
- 05
Project requirements
The client’s quality standards, corporate engineering standards, local codes and operational constraints.
References
References considered where applicable
Depending on the agreed basis, the design is developed with consideration for the following. Not every reference applies to every project.
- EDA
Egyptian Drug Authority
Requirements and guidance applicable to facilities supplying the Egyptian market.
- PIC/S
PIC/S GMP Guide
The GMP guide shared by the participating inspectorates of the Pharmaceutical Inspection Co-operation Scheme.
- EU GMP
EU GMP, including Annex 1
EudraLex Volume 4 and, for sterile products, Annex 1 on the manufacture of sterile medicinal products and its contamination control strategy.
- WHO
WHO GMP
World Health Organization good manufacturing practice guidance, often referenced for prequalification and many national markets.
- USP
United States Pharmacopeia
Relevant USP general chapters, for example on compounding and on water for pharmaceutical purposes, where the project follows USP.
- Ph.
Applicable pharmacopoeias
The pharmacopoeia selected for the products, such as the European, British or a national pharmacopoeia, especially for water grades.
- LOCAL
Market-specific regulations
Other authority requirements of the target markets, plus local building, fire, safety and environmental codes.
Design decisions
What the basis decides
The same room can need a different classification, pressure regime or containment approach in two projects. These decisions follow the selected basis and the process risk.
- 01
Cleanroom classification
Room grades and their limits are taken from the guidance in the agreed basis and the activities performed in each room.
- 02
Pressure relationships
Differentials and their direction depend on whether the room protects the product, the people, or both.
- 03
Containment philosophy
Primary controls, negative pressure and airlocks are selected from the hazard assessment and the product’s sterility needs.
- 04
Water and utility grades
Water and clean-utility qualities follow the products and the pharmacopoeia applied.
- 05
Qualification depth
The extent of commissioning and qualification reflects the system’s impact on product quality.
Responsibilities
Who approves what
- 01
ALVEDA SOLUTIONS designs facilities with consideration for the requirements applicable to the project. It does not certify facilities or grant approvals.
- 02
GMP certificates, licences and inspection outcomes are issued by the competent authorities to the manufacturer, after their own assessment.
- 03
The client’s quality unit owns the regulatory strategy, the contamination control strategy and the final acceptance of qualification.
Related
Where the basis is applied
Solutions
Next step
Agree the design basis before the first layout.
Tell us the product, the markets and where the project stands. An engineer will reply with the questions that set your basis.
+20 101 171 1700