GDP recommendations

Today, a quality management system such as ISO 9001 is standard throughout industry. A quality management system in accordance with GDP principles is not completely different, but has more focus on certain elements as described herein.

Organization and personnel focuses on qualification and approval of personnel for certain operations and adequate personnel hygiene procedures due to the nature and use of the products. Due to the specific application of excipients and the requirements of GDP principles, personal resources and the extent of training have to be adapted to the activities carried out.

Equipment highlights that equipment critical to product quality should be designed, installed, used, and maintained under full control. This approach takes into consideration that many equipment failures or a lack of cleanliness can have a detrimental effect on product quality. In addition to the recommendation to use dedicated equipment for product handling, guidance is given on how to design and control cleaning processes.

Documentation is a very important element of many GDP processes. Written procedures and complete records are crucial for the design of robust and consistent processes and for traceability of all operations. Therefore, in this chapter, essential document control processes are described. Beyond that, specific types of documents and their content are emphasized. Certificates of analysis (COA), for example, provide important information throughout the supply chain. The consistency of all associated documents and authenticity of recorded data are essential to ensure adequate control. Therefore, transcription of data, traceability to the original manufacturer's COA, batch integrity, and submission of such information are part of the guidance in this chapter. Another important documentation aspect is that associated with product labels. The reliability of the information on labels contributes significantly to the safe use of excipients. The control of label content and label generating systems has to be a documented process in a GDP system.

Repackaging and relabeling processes are performed by many distributors. Because these processes are considered to be manufacturing processes, the IPEC–PQG GMP Guidelines for Pharmaceutical Excipients (3) are referenced at this point in the GDP Guide. Nevertheless, not all parts of the GMP guide apply to distribution operations. To give guidance for distributors, specific processes are outlined in this section. For repackaging and relabeling operations, special attention should be given to the prevention of contamination and mix-up, hygiene, batch integrity, label control, and sampling. Although this is not a complete list, it shows that where excipients are exposed to the environment and compromise quality, several processes must be installed and maintained. In addition to the design of adequate processes, considerations also should be given to the appropriate repackaging environment, which may differ by product and application (e.g., clean areas, controlled environments). Control of packaging material quality comprises the quality of primary packaging components delivered by suppliers as well as their possible re-use. Both processes may significantly impact quality if not under control; GDP therefore requires documented processes and thorough controls. Labeling processes are considered manufacturing processes and should be designed and controlled as such. Batches should be formally released before further distribution.

Stability considerations should not be forgotten, specifically when excipients are repackaged into containers different from the packaging material used by the original manufacturer of the products. Generally, GDP requires appropriate analytical testing accompanying repackaging activities to demonstrate ongoing consistent product quality.

Complaints handling following GDP principles focus on systematic investigation of root causes and the documented definition of corrective and preventive actions. Furthermore, a risk-evaluation process of the affected batch and other batches must be part of the process to decide whether there is a risk to consumer health, ultimately requiring a recall. Communication with customers and original producers are required actions as part of complaint handling under GDP.

Recall is another crucial part of a GDP quality system. Recalls are not common in other quality systems. A recall process should be implemented to ensure that in the case of a product defect, all implicated material has to be withdrawn from the market to avoid any potential adverse effect to consumers.