I.B.11. Documentation of the quality system

Location:
I.B.

All elements, requirements and provisions adopted for the quality system shall be documented in a systematic and orderly manner in the form of written policies and procedures, such as quality plans, quality manuals and quality records [IR Art 8(4)].

A quality plan documents the setting of quality objectives and sets out the processes to be implemented to achieve them. A procedure is a specified way to carry out a process and may take the format of a standard operating procedure and other work instruction or quality manual. A quality manual documents the scope of the quality system, the processes of the quality system and the interaction between the two. A quality record is a document stating results achieved or providing evidence of activities performed.

In order to have a systematic approach, the organisation should define in advance:

  • quality objectives specific to their organisations in accordance with the overall quality objectives provided under I.B.4. and the structure- and process-specific quality objectives in accordance with each Module of GVP; and
  • methods for monitoring the effectiveness of the pharmacovigilance system (see I.B.12.).

The quality system shall be documented by:

  • documents on organisational structures and assignments of tasks to personnel (see I.B.11.1. and I.B.11.2.);
  • training plans and records (see I.B.7.) [IR Art 10(3), Art 14(2)];
  • instructions for the compliance management processes (see I.B.9.) [IR Art 11(1), Art 15(1)];
  • appropriate instructions on the processes to be used in case of urgency, including business continuity (see I.B.11.3.) [IR Art 10(4), Art 14(3)];
  • performance indicators where they are used to continuously monitor the good performance of pharmacovigilance activities [IR Art 9(1)];
  • reports of quality audits and follow-up audits, including their dates and results [IR Art 13(2), Art 17(2)].

Training plans and records shall be kept and made available for audit and inspection [IR Art 10(3), Art 14(2)].

It is recommended that the documentation of the quality system also includes:

  • the methods of monitoring the efficient operation of the quality system and, in particular, its ability to fulfil the quality objectives;
  • a record management policy;
  • records created as a result of pharmacovigilance processes which demonstrate that key steps for the defined procedures have been taken;
  • records and reports relating to the facilities and equipment including functionality checks, qualification and validation activities which demonstrate that all steps required by the applicable requirements, protocols and procedures have been taken;
  • records to demonstrate that deficiencies and deviations from the established quality system are monitored, that corrective and preventive actions have been taken, that solutions have been applied to deviations or deficiencies and that the effectiveness of the actions taken has been verified.

I.B.11.1. Additional quality system documentation by marketing authorisation holders

In addition to the quality system documentation in accordance with I.B.11., marketing authorisation holders shall document:

  • their human resource management in the pharmacovigilance system master file (PSMF) (see Module II) [IR Art 2(5)(b)];
  • job descriptions defining the duties of the managerial and supervisory staff [IR Art 10(2)];
  • an organisational chart defining the hierarchical relationships of managerial and supervisory staff [IR Art 10(2)];
  • instructions on critical processes (see I.B.11.3.) in the pharmacovigilance system master file (PSMF) (see Module II); and
  • their record management system in the pharmacovigilance system master file (PSMF) (see Module II) [IR Art 2(5)(c)].

It is recommended that the documentation of the quality system additionally includes the organisational structures and assignments of tasks, responsibilities and authorities to all personnel directly involved in pharmacovigilance tasks. For the requirements of documenting the quality system in the pharmacovigilance system master file (PSMF) or its annexes, see Module II.

I.B.11.2. Additional quality system documentation by competent authorities

In addition to the quality system documentation in accordance with I.B.11., the organisational structures and the distribution of tasks and responsibilities shall be clear and, to the extent necessary, accessible [IR Art 14(1)].

It is recommended that the documentation of the quality system additionally includes the organisational structures and assignments of tasks, responsibilities and authorities to all personnel directly involved in pharmacovigilance tasks.

Contact points shall be established [IR Art 14(1)], in particular to facilitate interaction between competent authorities, marketing authorisation holders and persons reporting information on the risks of medicinal products as regards patients’ or public health.

I.B.11.3. Critical pharmacovigilance processes and business continuity

The following pharmacovigilance processes should be considered as critical include:

  • continuous safety profile monitoring and benefit-risk evaluation of authorised medicinal products;
  • establishing, assessing and implementing risk management systems and evaluating the effectiveness of risk minimisation;
  • collection, processing, management, quality control, follow-up for missing information, coding, classification, duplicate detection, evaluation and timely electronic transmission of individual case safety reports (ICSRs) from any source;
  • signal management;
  • scheduling, preparation (including data evaluation and quality control), submission and assessment of periodic safety update reports; • meeting commitments and responding to requests from competent authorities, including provision of correct and complete information;
  • interaction between the pharmacovigilance and product quality defect systems;
  • communication about safety concerns between marketing authorisation holders and competent authorities, in particular notifying changes to the risk-benefit balance of medicinal products;
  • communicating information to patients and healthcare professionals about changes to the riskbenefit balance of products for the aim of safe and effective use of medicinal products;
  • keeping product information up-to-date with the current scientific knowledge, including the conclusions of the assessment and recommendations from the applicable competent authority;
  • implementation of variations to marketing authorisations for safety reasons according to the urgency required.

Business continuity plans should be established in a risk-based manner and should include:

  • provisions for events that could severely impact on the organisation’s staff and infrastructure in general or on the structures and processes for pharmacovigilance in particular; and
  • back-up systems for urgent exchange of information within an organisation, amongst organisations sharing pharmacovigilance tasks as well as between marketing authorisation holders and competent authorities.