Questions & Answers on Good Distribution Practices (GDP) - Part 3

In October 2020, the ECA offered the Live Online Training "The GDP Compliance Manager". During the Q&A sessions, many interesting questions were posed to the speakers' team. The ECA would like to share a selection of these Q&As sorted by topic.

Below you will find the third set of questions which have been answered by the speakers' team. Further Q&As will be published step by step within next weeks. All answers reflect the opinion of the speakers based on their experience.

Quality Management System (QMS)

Question 3.1: Do you think a change control (CC) is required for updates (including minor administrative revisions) to an SOP even if the document already has a revision history section?
Answer: This should be defined in your documentation policy/procedure. Some companies choose to use CC for document management; however, this may not be needed nor be appropriate for all organisations, you can use document history no problem and this is more manageable for most organisations.

Question 3.2: What is a Site Master File (SMF) in the context of GDP? Is it the same as a Quality Manual or does it require to establish a separate SMF if we have a Quality Manual?
Answer: SMF should provide full picture of the company's activities and how it is managed. Usually, a SMF is not seen in a wholesale environment as the Quality Manual will usually suffice. Where wholesale activities are undertaken by a manufacturer then a SMF will be in place. However, the requirements of your competent authority should be followed.

Question 3.3: Could you provide examples of departments with personnel considered to be involved in wholesale distribution activities?
Answer: This is very dependent on the nature and structure of the company along with how the company is established in relation to roles and responsibilities. Examples may include sales and marketing, operations, finance, reception, warehousing, transportation, quality department, human resources, customer services.

Question 3.4: Can one Quality Policy be covering multiple companies (e.g. one for several affiliates) or should every company owning a wholesale license have an individual quality policy?
Answer: Usually a company has one Quality Policy covering the Head Office and their affiliates. As long as the policy is relevant to all affiliates, then there is no problem. A Quality Management System should not be confused with Quality Policy.

Question 3.5: If corporate procedures are available, can they be implemented as such by an affiliate or are specific local procedures required?
Answer: Yes. It depends on the companies' organisation and their document hierarchy regarding which actions need to be taken. As long as all affiliates are part of the same quality system then implementation of Corporate Procedures might be feasible. Again: Depending on the defined document hierarchy and how each of the affiliates is set up to operate. Specific local procedures should be in use where Corporate Procedures are not sufficient to cover differences in affiliate activities. These procedures should constitute the company QMS and follow the same format. Guidance can be sought from the owners of the Corporate Procedures.

Question 3.6: Is it acceptable if we work with KPI's rather than quality objectives?
Answer: The GDP guidelines referred to quality system objectives and not KPI's; however, you may call them whatever you like as long as the metrics within the guidelines are reviewed and GDP activities are incorporated into your review process.

Question 3.7: What is the difference between Internal Audit and Self-Inspection?
Answer: These terms tend to be used interchangeably and have different definitions in different companies and different countries. The important part to remember is that you must, as per the GDP guidelines, have implemented a process to routinely review compliance with all aspects of GDP, regulations, guidelines and internal procedures. An Internal Audit could be performed by the RP or another department and the scope could be limited or broad, focusing on a specific area or the whole of the organisation's activities. With regards to GDP, ensuring Self-Inspection is performed is the responsibility of the RP and the schedule needs to cover all the GDP activities undertaken, cross-referencing to the EU GDP Guidelines, reviewing processes, procedures, staff understanding etc.

Question 3.8: Can QA role be delegated to operation person or person other than QA?
Answer: Due to the varying sizes of wholesalers to whom GDP regulations and guidance are applicable, the GDPs do not define which department personnel must work within. Therefore, it is the responsibility of the individual wholesaler to assess the right person for the right role and ensure their competence and ability to perform that role.