Global Regulatory Updates in Brief
This article was originally published in The Gold Sheet
Executive Summary
ICH updates Q7 with who-does-what answers; China aims to join PIC/S; ICH Q11 group to resolve issues face-to-face.
ICH Q7 Q&As: An API Whodunit
Though not as gripping as a whodunit paperback, the latest question-and-answer guidance from the International Conference on Harmonization does resolve some plot twists around who does what to ensure the quality of active pharmaceutical ingredients.
The “who” question has grown more complex in API manufacturing over the years, which is one reason ICH developed a Q&A document to update its nearly 15-year-old Q7 guideline on GMPs for APIs.
ICH formed an implementation working group three years ago to bring the Q7 guideline into accordance with subsequent ICH guidelines and changes in the industry and its regulatory oversight (Also see "ICH Works to Update API GMP Guideline with Q&A Document" - Pink Sheet, 19 Dec, 2013.).
Additional direction for the Q7 update came from a series of Pharmaceutical Inspection Cooperation Scheme, or PIC/S, workshops that yielded feedback from the world’s pharmaceutical inspectorates.
The Q&A document, published June 19, addresses some “who” questions that have arisen as outsourcing increased. For example:
- Who is responsible for issuing batch production records? The quality unit decides.
- Who can participate in transfers under quarantine to units under company control? Contract manufacturers can.
- Who is responsible for notifying whom about relevant changes in API manufacturing? Supply chain participants are responsible for notifying their customers.
The document answers additional “who” questions:
- API manufacturers cannot delegate responsibility for quality, but their contract manufacturers must also have independent quality units.
- Contract manufacturers can subcontract work to other parties if allowed by their contracts, and as long as it’s in writing and their customers approve each case in advance.
- If API distributors contract out production steps such as drying, micronization, milling or sieving, then they are manufacturers and are regulated as such.
The document also defines who can relabel APIs and who should be considered the original manufacturer of APIs.
The guideline addresses other types of issues as well. For example it:
- Recognizes that retests dates now can extend beyond three years after manufacturing, and that APIs may therefore remain on the market longer than envisaged in the original document;
- Clarifies that on-site supplier audits, while recommended, are not required; and
- Says there are situations where retrospective validation is still acceptable.
China prepares PIC/S bid
China’s FDA is considering applying to join the Pharmaceutical Inspection Cooperation Scheme, or PIC/S, the international association of pharmaceutical inspectorates.
PIC/S, which counts the U.S. FDA and the European Medicines Agency among its 46 members, promotes the enforcement of harmonized drug GMP standards by assessing inspectorates and providing them with training and networking opportunities.
China, the world’s foremost source of active pharmaceutical ingredients, has been strengthening its inspectorate in recent years in preparation for a bid to join PIC/S.
A CFDA delegation met with the PIC/S Committee in May to discuss a roadmap to membership and opportunities to begin working together on training and gap analysis.
“Once the feasibility study has been concluded, CFDA will have a clear picture on where it stands and when to apply [for PIC/S membership],” a PIC/S spokesperson told Scrip Regulatory Affairs
.
Meanwhile, China will co-host API inspection training in November with the PIC/S Expert Circle on API. The focus will be on the International Conference on Harmonization’s Q7 guideline on GMPs for API, which was recently updated with a Q&A document.
And the PIC/S Committee agreed at its May 11-12 meeting in Geneva to approve the Hong Kong Pharmacy and Poisons Board for membership.
ICH Q11 Q&A meeting planned
The steering committee of the International Conference on Harmonization agreed at its June 5-11 meeting in Fukuoka, Japan, to let its Q11 implementation working group conduct a face-to-face meeting in September to develop a question-and-answer document on the selection and justification of starting materials for the manufacture of drug substances.
China hits Gingko quality
Nearly half the samples of Gingko biloba extracts, tablets and capsules that China’s FDA tested were substandard, the agency said June 22.
The agency tested 5,161 samples from 90 manufacturers and found issues with 2,335 from 30 manufacturers, Pharmasia News reported (Also see "China Gingko Crackdown Reveals Broad Quality Problems" - HBW Insight, 29 Jun, 2015.).