Dave Rushton
Founder
of Paradigm Shift Consulting Limited.
Dave Rushton is Founder of Paradigm Shift Consulting Limited, a Good Distribution Practice Consultancy.
Documentation to GDP Compliance
GDP Compliance in Documentation
Documentation is an essential part of GDP, as it provides evidence of the actions taken by the distributor to demonstrate compliance with the applicable regulations and guidelines.
Documentation also facilitates traceability of the distribution process, enables effective recall of defective products, and supports continuous improvement of the quality system. In this blog, we will discuss the main types of documentation required for GDP compliance, and how Paradigm Shift Consulting Ltd can help you with your documentation needs.
Types of Documentation
According to the EU GDP Guidelines, the following types of documentation should be maintained by the distributor:
- Quality Manual: This is a high-level document that describes the quality policy, objectives, organisation, responsibilities and authorities of the distributor. It should also include a description of the quality system and its scope, as well as references to relevant procedures and instructions.
- Standard Operating Procedures (SOPs): These are detailed written instructions that describe how to perform specific tasks or operations in a consistent and compliant manner. SOPs should cover all aspects of GDP, such as procurement, storage, transportation, delivery, recall, returns, complaints, deviations, self-inspections, training and records management.
- Records: These are documents that provide evidence of the activities performed and the results obtained. Records should be clear, accurate, complete, legible and traceable. Records should be retained for at least five years after the expiry date of the product or one year after the product has been distributed, whichever is longer. Examples of records include purchase orders, invoices, delivery notes, temperature logs, stock records, batch numbers, expiry dates, audit reports and training certificates.
- Validation Documents: These are documents that demonstrate that the equipment, systems and processes used by the distributor are fit for their intended purpose and operate consistently and reliably. Validation documents should include validation plans, protocols, reports and data. Examples of validation activities include temperature mapping of storage areas and vehicles, qualification of suppliers and customers, verification of transport routes and conditions, and testing of computerised systems.
- Change Control Documents: These are documents that describe the proposed changes to the quality system or any aspect of GDP, and the rationale, impact assessment, approval and implementation of those changes. Change control documents should include change requests, risk assessments, action plans and effectiveness checks. Examples of changes that require change control include introduction of new products or services, relocation or renovation of premises, replacement or modification of equipment or systems, revision or deletion of SOPs or records.
The Responsible Person and Documentation
The Responsible Person (RP) is the person designated by the wholesale distributor to ensure compliance with the Good Distribution Practice (GDP) guidelines and regulations. They must also (as part of their duties) ensure that documentation is in order and correct to the ALCOA principle:
A – Attributable (Who wrote it and when)
L – Legible (It must be easy to read)
C – Contemporaneous (It must be made at the time of the action or incident)
O – Original (The 1st generation document only, and not filled in by a 2nd or 3rd party who was not involved).
A – Accurate (The data entry must reflect exactly all the details of the action or incident).
The RP’s role in good documentation is:
(i) Ensuring that a quality management system is implemented and maintained.
(ii) Focusing on the management of authorised activities and the accuracy and quality of records.
(iii) Ensuring that initial and continuous training programmes are implemented and maintained.
(iv) Coordinating and promptly performing any recall operations for medicinal products.
(v) Ensuring that relevant customer complaints are dealt with effectively.
(vi) Ensuring that suppliers and customers are approved.
(vii) Approving any subcontracted activities which may impact on GDP.
(viii) Ensuring that self-inspections are performed at appropriate regular intervals following a prearranged programme and necessary corrective measures are put in place.
(ix) Keeping appropriate records of any delegated duties.
(x) Deciding on the final disposition of returned, rejected, recalled or falsified products.
(xi) Approving any returns to saleable stock.
(xii) Ensuring that any additional requirements imposed on certain products by national law are adhered to.
The RP should have a written job description that defines their authority to take decisions with regard to their responsibilities. The RP should have personal knowledge of the products traded under the licence and the conditions necessary for their safe storage and distribution, have access to all areas, sites, stores and records which relate to the licensed activities, and regularly review and monitor all areas.
How Paradigm Shift Consulting Ltd Can Help You
Paradigm Shift Consulting Ltd is an ISO 9001:2015 certified consultancy providing training and quality management services to the pharmaceutical industry.
We can help you with your documentation needs by:
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- Reviewing your existing documentation and identifying gaps or areas for improvement.
- Assisting you in writing or updating your quality manual, SOPs and records in line with the current regulations and guidelines.
- Conducting validation activities for your equipment, systems and processes.
- Managing change control processes for your quality system or GDP operations.
- Providing training on documentation requirements and Good Distribution Practices for your staff.
We have a team of experienced consultants who can support you as contract Responsible Persons (RPs). We can also conduct third-party audits of your site or your nominated third-party logistics providers (3PLs), following MHRA inspection protocols.
If you are interested in our services or have any questions about documentation or GDP compliance in general, please contact us for a free short consultation over the phone on 0330 133 0920. Alternatively, you can email on info@gdptraining.co.uk or use the contact form below.
A selection of useful links associated with this subject are here.
EU GDP Guidelines (2013/C 343/01)
Chapter 4
Why Good Distribution Practice Matters
Online GDP Webinar for RPs and Management
GDP Compliance of Data Integrity