DArcy has drafted GMP SOPs for many clients. Like in the clinical arena, manufacturing is typically outsourced by sponsor companies and hence oversight and management of vendors is really important.
“Vendor selection, management and oversight” are critical SOPs that should be drafted and used by companies in the management of their vendors. In terms of GMP SOPs required, there are basic SOPs required for manufacturing of drug product/ substance and management of investigational product (Master Batch Records, Certificate of Compliance, Stability etc.). While GMP vendors will typically have their own SOPs, it is critical that sponsor companies have sight of these SOPs and are comfortable that they are robust. Typically Quality Technical Agreements between CMOs and sponsor companies will outline what SOPs are being followed and who is accountable for what.
