Author: Gloria Pang
The nature of GMP
As we know, the pharmaceutical industry follows Good Manufacturing Practice (GMP). GMP sets out the minimum requirements which manufacturers should meet to ensure the safety, efficacy, and quality of medicinal products as required by marketing authorization or product specification. This means that manufacturers should demonstrate a state of control, consistency, and compliance in their pharmaceutical operations.
However, this does not necessarily mean that GMP requirements are so rigidly written until manufacturers are left with no space of autonomy in adopting their own choice of manufacturing workflows and pharmaceutical technology. Quite the opposite, GMP requirements have been carefully updated over time, with the intention of preserving a reasonable measure of flexibility so that every manufacturer can exercise discretion in deciding how to best implement the necessary controls by using the most appropriate forms of design, processing techniques, and analytical procedures based on scientifically sound rationales. At the same time, such flexibility in GMP requirements enables manufacturers to use innovative approaches to achieve higher standards of product safety and quality through continual improvement. This is the reason why the term GMP is also expressed as cGMP, the letter c denotes current. It means that manufacturers are expected to adopt relevant technologies and ancillary controls that are up to date.
Besides current, the other tenet of GMP is risk-based. As a systematic and targeted risk-based approach, GMP requires manufacturers to define and justify for themselves why a certain practice is chosen to manage, for example, production control or equipment. Rationalization therefore becomes an integral part of risk-based decision making which underpins the level of effort, formality, and documentation for various GMP-related undertakings.
Indeed, the current and risk-based dimensions of GMP expect manufacturers to attain higher degree of understanding of material attributes, manufacturing processes, and related controls, and to stay abreast with the up-to-date forms of technology within that given space of flexibility and autonomy, considering factors such as scope of operations, complexity of processes, and appropriate use of finite resources. Any revision in product formulation and manufacturing process should be looked upon as opportunities to gain additional knowledge and to assess existing purposes, perspectives, and practical ways of doing things. In this manner, there is a strong obligation on the side of manufacturers to learn, and to keep learning for improvement.
Learning as a context-bound phenomenon
But how should we understand learning? First of all, I think we need to acknowledge that human cognition is always in dynamic transaction with the external world. Every human thought is a (re)construction, and that the memory we possess is not a 'stored' memory as if it is like a container. The human mind does not work like a drawer where knowledge can be neatly arranged as the accrued end-products of learning. If that is the way we see the nature of knowledge, then learning is nothing other than the transfer of information from active trainers to passive trainees. Secondly, it assumes that learning is stable, reproducible, and uniformly understood. Learning is, in fact, not just a process whereby knowledge is acquired – it also occurs when existing knowledge is applied in a new situation, the formation of new knowledge, or in combinations of any such similar process. In this way, learning is a process that is situated within a context as a result of the reciprocal, moment-by-moment, evolving interactions with the external world so that the acquisition and deployment of what is learnt for goal-directed, problem-solving tasks provide the means for knowledge (re)construction. The situated cognition theory posits that knowledge is context-bound or situation-dependent because much of what is learnt is specific to the situation in which it is learnt. The context encompasses cultural differences, social activities, motivations, personal inclinations, and the environment. All these interplaying variables manipulate the learning process, shape the mental models, and influence the learners’ sense of self-efficacy, orientation to learning, and readiness to learn. The question is, therefore, not about whether learning is effective, but rather when is learning likely to be effective?
To illustrate this stance, let me use ICH Q10 Pharmaceutical Quality System. This guidance posits that the methodology of CAPA should eventuate to product and process improvements and enhanced product and process understanding. This implies that effective learning should take place in the very approach of how we determine CAPA which may be ‘resulting from the investigation of complaints, product rejections, non-conformances, recalls, deviations, audits, regulatory inspections and findings, and trends from process performance and product quality monitoring’ (Section 3.2.2). Each of these problem situations have specific contexts which require us to collect information, analyze information, and take CAPAs appropriate to the effects of the non-conformities/potential problems encountered. Effective learning is more likely to take place in connection with the context that influences a particular problem-CAPA situation rather than simply concluding it as ‘recurring incident’ and following up with ‘re-training’. Therefore, during the root cause analysis of an investigation process, instead of solely looking for details and explanations from past experiences, greater emphasis should be placed upon evaluating the happenings that emerge from within that situation or the contexts of interactions.
The know-what, know-how, and know-why of learning
Based on personal experience on investigation handling, working with colleagues from different departmental functions provides the opportunity for an individual to understand how one’s work is inter-related, inter-connected, and integrated with those of others, thereby enabling a person to learn the importance of doing his/her own work properly, communicating appropriately, and evaluating a situation from a wider perspective. Also, in working as a team, people exchange views, ask questions, and clarify thoughts; they get to correlate the planned objectives and practical relevance of what they learn, to understand the implications of what they do in the team, and to initiate a purposive examination of one’s values and assumptions. Essentially, the characteristics of a sound learning process should be marked by: (1) constructive discourses, (2) critical analysis, (3) active participation, (4) alignment of multiple perspectives, (5) encouragement of shared ideas. Why not? Afterall, learning is strengthened through participatory interaction where people can exchange views and experiences with one another while collaborating as a team. Moreover, Albert Bandura, the Canadian-born American psychologist and originator of social cognitive theory, asserted that human beings do not learn much by isolated concepts. Instead, they look for meanings through co-relational relationships between situations, actions, and outcomes, and this is where the sense of purposefulness and engagement are developed.
Essentially, learning is a sense-making process and we use those meanings in thinking, solving problems, and decision making. Besides, the nature of society at any point in time may determine the relative emphasis placed on learning. The point is, therefore, not about whether we need to learn, but rather what does learning mean to us? It is when we understand the rationale of learning, we will know the promises of learning and the pitfalls of not learning. Meaningful learning should result not just in knowledge and skills development for the improvement (i.e., the know-what and know-how to stay current), it should also lead to a certain measure of change in the affective, cognitive, and behavioral dimensions of our being through informed rationalization (i.e., the know-why to stay risk-based).
Building new knowledge bases
Finally, we should remember that the human brain has never stopped fascinating us, the bigger environment has never stopped evolving, and the dialectical transaction between human cognition and situational contexts has never ceased. Hence, there is still much to explore about human learning including situated cognition, or at least to think about how best we can use it to strengthen the knowledge base of both individuals and organizations. For example, to evaluate a person’s ability to apply knowledge gained in one context to solve problems encountered in another context, or to consider how certain aspects of good practices at workplaces can be customized and transferred to other operations of the company. In this ever-changing world, it is not difficult to understand the need for people to acquire and revise their knowledge and/or skills that add value to their unique contributions to their organizations, and stay competitive in the labor workforce. But what is less obvious but of great importance is that creative and innovative thinking processes in human brains are built upon the foundation of lifelong knowledge and constant interaction with the external world. The brain continuously draws on this knowledge base to develop simple solutions to complex problems. Knowledge becomes the building blocks for innovation which is the top priority for many contemporary organizations. Thus, people and organizations wanting to stay competitive should explore every opportunity to add to their knowledge base. Simply attending a seminar or lecture will not lead to substantial learning. Rather, effective and purposive learning initiatives stem from active engagement including facilitation, simulation, and role play, and since we live in a fast-paced world with ever increasing sensory overload, we need learning opportunities that are well designed order to make the best use of the limited time available for us to build new knowledge bases.
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