CDMO manufacturing for several clients; batch review and release
Batch release, unblocked — contract development and manufacturing organisation
The challenge, in operational terms
A busy CDMO was manufacturing for several clients, and final batch review and release had become the bottleneck. Documentation review was slow, the same minor gaps kept recurring, QA and production had different priorities, and staff didn't share the same understanding of what compliance actually required. It was a customer satisfaction problem and a compliance one at the same time.
What I did, including the assessment method
I assessed the current review and release process, built a list of the recurring documentation errors, then ran a joint session with production and QA supervisors to work through solutions together. A batch review procedure came out of that session, and tailored training was delivered to both groups.
The result
Mapping the process alongside the people who run it surfaced duplicated activities, genuine logistical constraints and the gap in compliance understanding between staff. Because production and QA were both in the room for the mapping and the brainstorming, the solution had real ownership and the procedure actually got used. Redundant steps came out, target timelines went in for each stage, and the project deliverable timeline was met.
Related services
GxP Compliance Assessments
An honest, prioritised picture of where you stand against the regulations that apply to you. Includes preparing for an inspection, addressing findings after one, and identifying areas for improvement.
For: companies who suspect something isn't right but can't name it or size it.
Customised Training
Training built around your organisational needs, for the roles that need it, with reinforcement afterwards to check it landed.
For: companies whose training records are complete and whose practice isn't consistent.
Who you'd be working with.
I'm Antiksha Joshi. I've spent 28 years in pharmaceutical and life sciences quality across three continents. I am Chair of Women in Pharma, ISPE Australasia Affiliate.
I also write and speak on quality systems for various knowledge sharing organisations and online publications.
My background is in microbiology, and I hold a diploma in counselling, which sounds like an odd combination until you've watched a technically sound quality system fail because nobody could be persuaded to use it.
Whoever you speak to on the call is the person who does the work.
