Manufacturing a sterile product by sterilising components and solution separately and assembling them under conditions that prevent contamination, used when the product cannot survive terminal sterilisation.
The authorised document for a batch, completed as the batch is made, recording every material, parameter, check and signature — the primary evidence that a batch was made as approved.
Demonstrating that cleaning between products leaves no more than the maximum allowable carryover, calculated from toxicological or dose-based limits and verified analytically.
Engineering and procedural controls that keep operator exposure to a potent compound below its occupational exposure limit, banded into occupational exposure bands from OEB 1 to OEB 5.
A full-scale trial batch run to confirm the process on the receiving site's equipment before validation batches, usually not intended for commercial sale.
Cleanroom classifications for sterile manufacturing — Grade A is the critical filling zone, Grade B its immediate background — defined by particle counts at rest and in operation plus microbiological limits.
The ICH guideline that defines stability testing requirements for new drug substances and products — storage conditions, testing frequency and data needed to support a shelf life.
Manufacturing at another company's licensed premises under a licence issued in the marketing company's name, with defined oversight of the batch by the licence holder's QA.
A stability result that is still within specification but has moved away from the established trend — an early warning that a specification failure may be coming.
Testing a product's response to light exposure, using defined visible and near-UV doses, to decide whether light-protective packaging or labelling is required.
The written agreement defining who is responsible for which GMP activity between the contract giver and the contract acceptor — release, change control, deviations, audits and recalls.
The period during which a product remains within specification when stored under the conditions on its label, supported by stability data rather than extrapolation alone.
The documented handover of a product and its process from one site to another, so the receiving site can make it to the same specification with evidence rather than hope.