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Pharmaceutical Technology APIs, EXCIPIENTS, AND MANUFACTURING eBOOK 2021 61 of product 'quantum leap' increases of knowledge may occur typically originating by changes in technology or by trouble-shooting activities due to manufactur- ing problems. It is of utmost importance that these increases in product/process knowledge are captured and consolidated in company documentation. Quality system-related knowledge is more in line with good practice (GxP) guidelines—regulatory in nature and typically developed through adaptation to changing laws and guidelines, self-assessments, au- thority inspections, and deficiency letters. This type of knowledge is usually kept and maintained in policies, procedures, and manuals, and is less impacted by the type of products manufactured and the field of activ- ity of the company than the product/process related knowledge. Several quality system elements (e.g., how to manage complaints or changes) are independent of the technology in place for manufacturing. Being related to regulatory aspects, this type of know-how is usually impacted by the regulatory classification of products (prescription vs. over-the-counter [OTC], generic vs. proprietary, biotech vs. small molecule vs. advanced medicinal therapy product [ATMP]), and by the reference market (worldwide vs. local). Internal vs. external knowledge. Another way to classify knowledge is its origin. We can distinguish between knowledge internally developed in the company from the one gained by means of external contacts and re- lationships. The classification is not of minor impor- tance as it impacts significantly on the methods neces- sary to capture and consolidate the know-how. Internally developed knowledge originates from routine activities performed according to company procedures. Despite being standard processes, these activities always generate new information on pro- cesses and products. In this case, knowledge develops and increases in the frame of standardized process. This is quite evident in development activities where, by definition, knowledge about products and processes builds up by following standard company develop- ment procedures. The quality-by-design (QbD) ap- proach in development activities facilitates and further strengthens knowledge build up and capture in this crucial phase of product lifecycle. The importance of the knowledge gained during pharmaceutical development activities is empha- sized in ICH's Q8 guideline (3). It is in pharma- ceutical development that the knowledge is created leading to product and process understanding and product realization after transfer to the manufactur- ing site. A pharmaceutical development department plays a central role in the development phase of a product, not only from the technical point of view but also due to collaborative interactions with most of the company functions, as illustrated in Figure 2. This is a unique opportunity for people to gain knowledge and grow professionally. In view of the inherent complexity of product development, it is evident that empiricism or personal initiative would never allow these goals to be achieved. There must be an integrated knowledge management system. One example of internally developed knowledge during manufacturing is process validation. By per- forming this exercise, companies develop significant information about the impact of material attributes and process parameters on product quality. This is the case in both prospective validation and ongoing process verification. The knowledge gathered is usually captured in process validation reports. Another opportunity to internally develop knowl- edge on products and processes is the management of nonconformities. Deviations in the manufactur- ing process or in the stability profile of some batches trigger investigations, which result in an increased