Pharmaceutical Excipient GMP/GDP

EXCiPACT is an independent, voluntary certification scheme for suppliers of pharmaceutical excipients — the substances in a medicine that are not the active ingredient: binders, fillers, coatings, preservatives, solvents, colourants.

Excipients typically make up most of a finished dosage form by mass, and their quality directly affects the safety, stability and performance of the drug. But excipients are usually manufactured in chemical plants serving many industries, not in pharmaceutical facilities, which historically left drug manufacturers with a difficult assurance problem.

EXCiPACT solves it by combining ISO 9001 with pharmaceutical GMP and GDP annexes written specifically for excipients. Auditors are qualified under ISO 17021 competence rules, certification bodies are approved by EXCiPACT, and the certificate runs for three years with annual surveillance audits.

The commercial logic is straightforward: one credible third-party certificate replaces a long queue of individual customer audits.

It is a fit for:

• Manufacturers of pharmaceutical excipients
• Distributors, repackagers and traders of excipients
• Chemical manufacturers with a product line sold into pharmaceutical use
• Suppliers to companies subject to EU GMP Part I and its excipient risk-assessment obligations
• Organizations facing repeated customer audits and wanting to consolidate them

The driver is usually your customers. Drug manufacturers carry a regulatory duty to assess the risk of their excipient supply, and an EXCiPACT certificate is a recognized way of discharging much of that assessment. Suppliers who hold it get shortlisted; suppliers who do not get audited, repeatedly, by every customer separately.

If your quality team is spending significant time hosting customer audits that all ask the same questions, that is the business case.

The scheme is ISO 9001 plus excipient-specific GMP and/or GDP requirements. You certify to the GMP annex if you manufacture, the GDP annex if you distribute, or both.

The additions over a plain ISO 9001 system include:

• Contamination and cross-contamination control — particularly important where excipient production shares a site or equipment with industrial-grade chemistry
• Change control — formal management of changes affecting excipient quality, with customer notification obligations
• Traceability and batch records through manufacturing and distribution
• Water and utility quality where they contact product
• Cleaning validation and equipment qualification
• Supplier qualification for raw materials and outsourced activities
• Storage, transport and temperature control under the GDP annex
• Deviation, complaint and recall procedures
• Personnel hygiene, training and competence appropriate to pharmaceutical supply
• Documentation and data integrity for records supporting excipient quality

Certification is performed by an EXCiPACT-approved certification body: a Stage 1 documentation review, a Stage 2 on-site audit, then a three-year certificate maintained by annual surveillance.

We bring 30+ years of building quality systems, 900+ organizations certified and a 100% first-time pass rate, with substantial pharmaceutical and medical experience — ISO 15378 for primary packaging, ICH Q7 for active ingredients, ISO 13485 for devices.

The challenge with EXCiPACT is almost always the same, and it is cultural rather than technical: the site is a chemical plant being asked to behave, for one product line, like a pharmaceutical operation. Change control, cleaning validation, data integrity and deviation management are unfamiliar disciplines in that environment. Our job is to introduce them in a way the plant can actually run, applied where they matter rather than everywhere.

We start with scope — which products, which annex, which parts of the site — then build the system with your team on top of your existing ISO 9001 where you have it. We train the people who will operate it, run an internal audit tougher than the certification body's, and support you through Stage 1 and Stage 2.

You get single-level documentation, typically under 200 pages, and most organizations certify in about 5 to 9 months.

• Certifying the wrong annex — GMP when you distribute, GDP when you manufacture, or missing that you need both
• Scoping the whole chemical site into a pharmaceutical-grade system when only one product line requires it
• Weak change control, so a process change reaches customers without notification — one of the most damaging findings possible
• No real cleaning validation where equipment is shared with industrial-grade production
• Data integrity gaps in records supporting excipient quality
• Treating GMP as a documentation exercise while plant behaviour stays unchanged
• Assuming ISO 9001 covers it — the pharmaceutical annexes are the substance of the scheme
• Underestimating supplier qualification for incoming raw materials