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GMP Validation Scope.

Online Validation requires the following procedures, processes and designs changes to be documented, approved and issued by Change Control . Once in use these procedures must be subjected to strict change control procedures and a rigorous system of routine and random audits that will produce documented evidence that these procedures are correct and are being applied in all aspects of cGMP compliance requirements. (21 CFR Part 820.70 relates). (21 CFR Part 211.100(a) relates).

Operators must receive sufficient training to enable them to proficiently and diligently work in accordance with these cGMP Validation document procedures. (21 CFR Part 820.25(b) relates). (21 CFR Part 211.25(a) relates).

Documented directives and techniques must be written in clear and unequivocal language. Within the industry these instructions are referred to as Standard Operating Procedures or SOP?s. (21 CFR Part 70(1) relates). (21 CFR Part 211.)

Production records that record and therefore verify that all the specified manufacturing parameters; either manually observed or electronically recorded, have been complied with must be identified with all the relevant product identifications and securely retained. (21 CFR Part 820(2) relates) (21 CFR Part211.100(b) relates).

All deviations from these documented expectations that occur during product processing thoroughly investigated and the findings documented. (21 CFR Part 820.70 relates).

All records generated during manufacturing and distribution that are mandated as essential in establishing the entire manufacturing history of a product batch; to be traced, must be kept and retained in a secure, comprehensible and readily accessible form. (21 CFR Part 820.180(b) relates) (21 CFR Part 211.110(c) relates)

Product distribution, transit and storage conditions must ensure that the product efficacy, quality and records are never compromised. (21 CFR Part820.140 relates). (21 CFR Part 211.180(a) relates)

There must be a system in use that ensures all complaints about marketed products are promptly and diligently examined and the causes of quality defects investigated. (21 CFR Part 820.100(a) relates). (21 CFR Part 211.198(a) relates)

Where statistical analysis is used to verify the acceptability of a process capability, then there must be documented validation of the robustness and accuracy of this analysis procedure. (21 CFR Part 820.250(a) relates). (21 CFR Part 211.160(a) relates).


Online Validation Audit.

Audit Preparation - For successful online validation the Quality Auditor (team leader) must review all applicable change control records subsequent to a design transfer, any FDA clearance delay information, recall records, standard manufacturing procedures, device histories, complaint history, device labels and inserts, previous audits with results, follow-up audits, plus any other document relative to the online validation audit.

Audit Initiation - The Quality Auditor prepares/updates an audit checklist for systematic examination of the area to be audited, informs the Manager of the department being audited at the start of the audit, and reviews observations with the Department Manager.

Audit Analysis - The Quality Auditor reviews the data gathered, verifies important details, and writes an audit report according to the format delineated in the attached audit report outline.

Issuance of Audit Report - The Quality Auditor issues the written audit report to the President and Department managers within three working days following completion of the audit. If conditions are critical, the Director of Quality Assurance shall verbally brief appropriate staff members within 12 hours following audit completion. Audit reports shall be stamped "Confidential".

Corrective Action - The appropriate Management staff member shall be responsible for developing a schedule for correcting deficiencies cited in the audit report and submitting same within five working days to the Quality Assurance Manager. Included in the correction schedule shall be the responsible individual, and the date when corrective action will be completed. The Manager of Quality Assurance shall act as arbiter, if necessary, to judge validity of the deficiency, responsible individual, and reasonable date to complete the corrective action.

Audit Follow Up - The Quality Auditor maintains a log listing deficiencies, responsible individual, target date for corrective action, and actual date of correction. If the same deficiency occurs on a second follow-up audit, the President shall be notified in writing by the Quality Assurance Manager.

Log of Audits and Follow-up Audits - The master log shall be maintained by the Senior Quality Auditor. The audit log file shall include a copy of current audits, list of areas to be audited during the 12-month period, and list of areas audited to date (i.e., part of the Master Log).