Established Quality Unit
- Independent Quality Unit established from Operations (Organogram).
- Quality unit position job descriptions established.
- Quality unit responsibilities defined in controlled documentation.
- Quality Manual, Site Master File, Quality Policy or Equivalent established.
Established process for release of components and in-process materials
- Procedure(s) in place/use defining ordering from approved supplier list, establishing component specifications, sampling, testing, acceptance criteria, roles of QC, warehousing, procurement, final release, issuance of certificates, inventory disposition instructions.
- The training system identifies appropriate core stakeholder groups that receive initial and periodic re-training in the associated procedure(s).
Established process for batch disposition
- Procedure(s) in place/use defining the production and quality authority activities, responsibilities and checks/verifications performed and their associated sequencing. The procedure defines the associated documentation completed and certificates issued. Traceability of all material is assured and compliance with specifications verified.
- The training system identifies appropriate core stakeholder groups that receive initial and periodic re-training in the associated procedure(s).
Established process for TSE/BSE control
- Procedure(s) in place/use, including within the scope facilities, equipment, materials, consumables, supplier qualification, specification, goods receipt checks and certificate issuance.
- Records of specifications, certificates/records received and issued, retained on file in accordance with an archiving or document retention procedure.
- The training system identifies appropriate core stakeholder groups that receive initial and periodic re-training in the associated procedure(s).
Established process for document control
- Procedure(s) in place/use, including initial induction, training, annual GMP and various approaches to training and qualification for permanent and contractor (temporary) personnel.
- Tracking system established for record assignment and status control.
- The training system identifies appropriate core stakeholder groups that receive initial and periodic re-training in the associated procedure(s).
Established process for training control
- Procedure(s) in place/use, including initial training and induction, annual GMP and various approaches to training and qualification.
- Tracking system established for record assignment and status control.
- The training system identifies appropriate core stakeholder groups that receive initial and periodic re-training in the associated procedure(s).
Established process for change control
- Procedure(s) in place/use, including change initiation, triage, approval.
- Tracking system established for record assignment and status control.
- The training system identifies appropriate core stakeholder groups that receive initial and periodic re-training in the associated procedure(s).
Established process for deviation, event and/or non-conformance, CAPA & effectiveness check management
- Procedure(s) in place/use, including documentation, reporting, timelines, classification, investigation, impact assessment, root cause/causal analysis, CAPA, effectiveness check and post approval requirements.
- Tracking system established for record assignment and status control.
- The training system identifies appropriate core stakeholder groups that receive initial and periodic re-training in the associated procedure(s).
Established process for Qualification program
- Procedure(s) in place/use for basic Qualification (not Validation) program, including facilities, utilities, equipment and analytical.
- Program or schedule established for tracking and review of initial and requalification.
- The training system identifies appropriate core stakeholder groups that receive initial and periodic re-training in the associated procedure(s).
Established process for Quality Risk Management (QRM)
- Procedure(s) in place/use for QRM
- Risk register, program or schedule established for tracking and review of risk assessments.
- The training system identifies appropriate core stakeholder groups that receive initial and periodic re-training in the associated procedure(s).
Established process for supplier qualification and management
- Procedure(s) in place/use for material procurement and supplier request.
- Procedure(s) in place/use which provides structure for evaluation, approval and disqualification.
- Approved supplier (vendor) list, managed by the Quality Unit.
- The training system identifies appropriate core stakeholder groups that receive initial and periodic re-training in the associated procedure(s).
Established process for external audits
- Procedure(s) in place/use for the approval of external auditors, including process for training, approval and continuing education (professional development).
- Procedure(s) in place/use for performing an audit from planning to close-out.
- Program or schedule for planning, tracking external audits and associated responses.
- The training system identifies appropriate core stakeholder groups that receive initial and periodic re-training in the associated procedure(s).
Established process for internal audits (self-inspection)
- Procedure(s) in place/use for the approval of internal auditors, including process for training, approval and continuing education (professional development).
- Procedure(s) in place/use for performing an audit from planning to close-out.
- Program or schedule for planning, tracking internal audits and associated responses.
- The training system identifies appropriate core stakeholder groups that receive initial and periodic re-training in the associated procedure(s).
Established process for Quality Management Review
- Procedure(s) in place/use, defines the key KPIs measured, trending performed, minimum attendees, minimum frequency and how notes or actions are taken.
- The training system identifies appropriate core stakeholder groups that receive initial and periodic re-training in the associated procedure(s).
Established process for non-medical complaint management
- Procedure(s) in place/use, inclusive of complaint intake, triage, notification to management, investigation, CAPA, response and closure.
- Tracking system established for record assignment and status control.
- The training system identifies appropriate core stakeholder groups that receive initial and periodic re-training in the associated procedure(s).
Established process for product recall (stock recovery).
- Procedure(s) in place/use, inclusive of recall investigation, escalation, decision authority, competent authority notification, CAPA, notification, reconciliation and closure.
- Procedure requires an annual mock recall (simulated recall) is performed if an actual recall is not performed for the given period. Mock recall performed out of hours. Mock recall is documented and used to evaluate the effectiveness of current arrangements.
- A tracking system was established for recall progress and reconciliation.
- The training system identifies appropriate core stakeholder groups that receive initial and periodic re-training in the associated procedure(s).
Established process for defect management and reporting
- Procedure(s) in place/use, inclusive of material specifications, notification to management, reporting, investigation and risk-based assessment.
- Visual inspection program established, including establishing defect library, categorization, visual inspection challenge kits, inspector qualification (initial/periodic) which maybe be by either/both manual operator or validated camera systems.
- Defects are trended, investigated, with a risk-based assessment to support lot disposition decision making (inherent or extraneous defects, or equivalent).
- The training system identifies appropriate core stakeholder groups that receive initial and periodic re-training in the associated procedure(s).
Established process for product returns
- Procedure(s) in place/use, defines a return, how this is notified, physically received, triaged, quality authority decision making, assessment criteria, quarantine receipt process, returned to stock or destroyed. A timeline is defined within the procedure to permit the processing of a return. The potential for the return to have been handled incorrectly or outside the legitimate supply chain is included within the procedure.
- The training system identifies appropriate core stakeholder groups that receive initial and periodic re-training in the associated procedure(s).
Established inspection readiness program
- Procedure(s) in place/use, considers the logistical arrangements, training in how to manage inspections, communication with an inspector, and identification of high-risk items considered an inspection risk and the associated management of the same. Procedure manages both announced and unannounced inspections.
- The training system identifies appropriate core stakeholder groups that receive initial and periodic re-training in the associated procedure(s).
- Certified, licensed, and/or accredited by the relevant authorities
- Current applicable licenses and certifications in place
