A GxP-compliant process landscape as part of a QMS based on ISO 9001
1. Objective
As virtually every SME nowadays uses standardized processes, which are generally based on an ISO quality management system, many pharmaceutical companies are interested in integrating GxP requirements into ISO 9001:2000.
2. Starting point
The starting point for many pharmaceutical companies can be summed up by the following points:
- Specific customers and local or international organizations require the company to meet GxP-related regulatory requirements.
- Highly complex business processes in the pharmaceutical, medical technology and chemical industry are generally managed using an ISO quality management system.
- A closely related issue is the validation of computer systems which support the internal GxP processes.
- Both the validation of a computer system and the maintenance of the validated state results in an average increase in the workload of 15 to 30%.
- Separating the regulatory environment from the remainder of the company's operations results in a high level of investment and high running costs (everything is duplicated).
- The understanding that consistently incorporating quality into the company's day-to-day work results in costs being incurred but also brings fundamental benefits (reduction in the cost of errors, knowledge transfer, process improvements etc.).
3. Problem
The question when representing GxP-based business processes therefore concerns the amount to which they overlap with ISO 9001:2000 and how they are managed in operational terms in order to reduce the number of redundant process steps. To support GxP-related business processes in the pharmaceutical industry, a quality management manual is needed to define the mandatory corporate quality procedures. Standard underlying processes must also be described which represent the requirements of ISO 9001 and GxP in the activities to be controlled. One example of this is batch traceability.
4. Approach
A structured approach to analyzing and defining the necessary adaptations is recommended and will bring benefits. For this purpose, Arcondis has developed the hierarchical approach of the following quality system levels (orange, red and green) which can be used for the company's entire process map:
- a) Quality management manual (QM manual)
- b) Standard operating procedures based on standards and legal requirements (SOPs, TOPs, control processes)
- c) IT infrastructure qualification
The documents created and used in the quality system are stored and managed in a document management system (DMS) which supports a hierarchical workflow.
* Integrative, standardized document management and storage
The document hierarchy is as follows:
The QMM defines and specifies the requirements for the entire quality management system. The SOPs describe the individual business processes at the levels of the management, the value added chain and the supporting processes. The TOPs form the third level and cover the technical procedures and operational implementation, for example in the ERP, LIMS and/or MES systems.
An integrated document management system for the business processes allows the training requirements for personnel management based on GxP to be fully incorporated. We recommend that they are structured according to positions and functions, in order to allow operational qualification management to be put in place for the assigned tasks.
5. Solution
Our standardized solution for integrating ISO and GxP requirements is based on the legislative hierarchy and the accompanying subsidiary internal guidelines. The objective is to harmonize the different interests involved and eliminate redundancy.
The following points (in sequential order) describe our approach:
- a) Description of the relevant legal position for the customer's product range.
- b) Internal strategic and operational requirements, such as the business manual and organizational regulations, together with the results of internal and external inspections.
- c) Existing or new quality system and classification guidelines for the customer's product range.
- d) Structure of the supporting IT systems required to create the business processes.
6. Recommendation
Any company can incorporate this approach into its own QM activities. We recommend that every organization which is working toward standardizing its processes in a QMS and aiming to integrate the product-based legal GxP requirements at the same time and which needs more information should make contact with Arcondis without obligation by e-mailing info@arcondis.com or daniel.ebner@arcondis.com.