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Components of Good manufacturing Practices Compliance Programme

Administrative Arrangement under Article 15.3(e) of the Protocol on the Mutual Recognition of the Compliance and Enforcement Programme regarding Good Manufacturing Practices for Pharmaceutical Products

This administrative arrangement is not intended to create rights or obligations under international or domestic law and, in line with Article 15(7) of the Protocol, is not subject of the provision of Chapter 29 of the CETA Agreement.

Between DG SANTE and Health Canada

Friday, November 16, 2018

DG Santé is a Directorate General of the European Commission.
Health Canada is a Federal department of the Government of Canada.

This administrative arrangement has been approved by the European medicines Agency (EMA) and the competent authorities of the Member States.

1. Introduction

The components of a good manufacturing practices compliance programme are part of the main elements of the CETA GMP Protocol to the Mutual Recognition of the Compliance and Enforcement Programme regarding Good Manufacturing Practices for Pharmaceutical Products (CETA GMP Protocol) which the Participants, through the Joint Sectoral Group (JSG), are required to establish through an Administrative Arrangement pursuant to Article 15.3(e) (GMP Compliance Programme).

2. Purpose

This Administrative Arrangement provides the components of a GMP Compliance Programme recognized by EU and Canadian Regulatory Authorities.  It represents the components on which a new Regulatory Authority (Article 12) will be evaluated to be formally recognized.

It also represents the components re-evaluated under the maintenance programme (Article 13) (partially or completely), in order to confirm the maintenance of an equivalent status.

3. Scope

This “Components of a Good Manufacturing Practice (GMP) Compliance Programme” (the Programme) applies to:

• a.   Regulatory Authorities listed in Annex 2 to the CETA GMP Protocol which were found equivalent after the initial confirmation pursuant to provisions of Article 12 Equivalence of new regulatory authorities of the CETA GMP Protocol;

  b.   Regulatory Authorities that are legal successors of the authorities referred to in paragraph (a);

  c.   Regulatory Authorities which were recognized as equivalent under the EU-Canada Mutual Recognition Agreement (MRA) of 14 May 1998 and which remained equivalent at the time of entry into force of the CETA;

  d.   New regulatory authorities seeking recognition of their equivalency under Article 12 of the CETA GMP Protocol.

4.   Components of a GMP Compliance Programme

• 4.1 Legislative and Regulatory Requirements and Scope

  • a.   Empowering legislation and regulations including authority to enforce laws and regulations, powers given to inspectors to conduct inspections, authority to remove violative products from the market, GMPs are legal requirements;

    b.   Suitable controls on conflict of interest.

  4.2 Regulatory Directives and Policies 

  • a. Procedures for designating inspectors;
  • b. Enforcement policies/guidelines/procedures (inspection, re-inspection, corrective action);
  • c. Codes of conduct/ethics;
  • d. Training/certification policies/guidelines;
  • e. Alert/crisis management policies/procedures/guidelines;
  • f. Organizational structure, including roles, responsibilities and reporting relationships.

  4.3 Good Manufacturing Practices (GMP) Standards

  • a. Scope/details of GMPs necessary for the control of the manufacturing of drug products;
  • b.  Process validation requirements.

  4.4 Inspection Resources

  • a. Staffing – Qualifications are defined and certification of inspectors;
  • b. Number of inspectors in relation to size of industry;
  • c. Training/certification programmes/processes (e.g., frequency of training) and effectiveness of training programmes.

  4.5 Inspection Procedures (pre-inspection, inspection, and post-inspection activities)

  • a.   Inspection strategy (type, scope, scheduling, focus of inspection, notification of inspections, risk based inspections);
  • b.   Pre-inspection preparation/requirements;
  • c.   Inspection methodology (access to and review of firms’ files and databases, collection of evidence, data review, sample collection, interviews);
  • d.   Procedures (SOPs) for inspection;
  • e.   Format and content of inspection reports, including support tools (e.g., hardware);
  • f.    Post-inspection activities (procedures for report issuance, follow-up, decision making);
  • g.   Storage of inspection data.

  4.6 Inspection Performance Standards

  • a.   Frequency/number of inspections, quality and timeliness of inspection reports, norms/frequency/procedures for re-inspection and corrective action.

  4.7 Enforcement Powers and Procedures

  • a. Provision of written notices of violation to firms;
  • b. Non-compliance management procedures/mechanisms (recall, suspension, quarantine of products, licence revocation, seizure and prosecution);
  • c. Appeal mechanisms;
  • d. Other measures to promote compliance by firm.

  4.8 Alert and Crisis Systems

  • a.   Alert mechanisms (Two-Way Alert System);
  • b.   Crisis management mechanisms;
  • c.   Alert performance standards (appropriateness and timeliness of alert).

  4.9 Analytical Capability

  • a.   Access to laboratories with capacity to handle necessary analysis;
  • b.   Procedures (SOPs) for analytical support;
  • c.   Processes for validation of analytical methods.

  4.10 Surveillance Programme/Measures (used by firm and by regulatory authority)

  • a.   Sampling and audit procedures;
  • b.   Recall monitoring (including effectiveness controls and verifications of procedures);
  • c.   Consumer complaint system/procedures;
  • d.   Medicinal / Drug product defect reporting system/procedures.

  4.11 Quality Management Systems

  • a. Quality management system/procedures recognized internationally to ensure the ongoing suitability and effectiveness of policies, procedures, guidelines and systems used to achieve the objectives of the GMP compliance programme, including establishment of standards and annual audit and review.

The above components are aligned with internationally harmonised standards and supplemented with details in the common audit checklist which is adopted individually by each participant.

For the EU: the latest version of the checklist, also referred to as Evaluation Guide for GMP Regulatory  Compliance Programme (Audit checklist), is available on the website of the European Medicines Agency.

For Canada: the latest version of the checklist is POL-0049, Mutual Recognition Agreement Evaluation Framework of Good Manufacturing Practices Compliance Programs, Appendix C- MRA Evaluation Guide and is available on the website of Health Canada.