taken or conclusions reached, where appropriate, for validation; requirement to the following examples: have those equipment assembly and calibration; documents is not Validation and qualification of processes, maintenance, cleaning and sanitization; new, as equipment and systems; performing and personnel matters including training, clothing, recording those Equipment assembly and calibration; hygiene; activities was Technology transfer; environmental monitoring; already required elsewhere in the Maintenance, cleaning and sanitation; pest control; Guide to GMP, Personnel matters including signature lists, complaints; only the fact that training in GMP and technical matters, clothing a document was recalls; and hygiene and verification of the required to do so effectiveness of training; returns wasn’t Environmental monitoring; mentioned in this clause yet Pest control; Complaints; Recalls; Returns; Change control; Investigations into deviations and Internal quality/GMP compliance audits; Summaries of records trial appropriate (e.g. product quality review); Supplier audits.
taken or conclusions reached, where appropriate, for the following examples: Validation and qualification of processes, equipment and systems; Equipment assembly and calibration; Technology transfer; Maintenance, cleaning and sanitation; Personnel matters including signature lists, training in GMP and technical matters, clothing and hygiene and verification of the effectiveness of training; Environmental monitoring; Pest control; Complaints; Recalls; Returns; Change control; Investigations into deviations and Internal quality/GMP compliance audits; Summaries of records appropriate (e.g. product quality review); Supplier audits. validation; equipment assembly and calibration; maintenance, cleaning and sanitization; personnel matters including training, clothing, hygiene; environmental monitoring; pest control; complaints; recalls; returns requirement to have those documents is not new, as performing and recording those activities was already required elsewhere in the Guide to GMP, only the fact that a document was required to do so wasn’t mentioned in this clause yet trial
consult-manuf-automatic-adoption-pics-130529-comparison.docx