In order to maintain a quality culture, Rajashri Survase-Ojha, Founder and MD, RAAJ GPRAC advises that organisations must maintain an awareness of quality as a key cultural issue, make sure that there is plenty of evidence of the management’s leadership, empower employees and encourage self-development and self-initiative and finally, recognise and reward the behaviours that tend to nurture and maintain a quality culture
GMP is all about people and how they should behave while manufacturing medicines. Why is it all about people? Because only people can practice. The emphasis is on the word ‘practice’ because practice becomes a habit, becomes an attitude, becomes the culture. cGMP (Current Good Manufacturing practice) compliance is of paramount importance to the success of the pharma industry’s success. This can be measured in terms of observations from FDA inspections and product recalls. The number of recalls reported in the US by US FDA in January-December 2016 totalled 1231, decreased to 1078 in January-December 2017 and once again increased to 1405 in January-December 2018.
US FDA observations (483s) increased from 678 in October 14-September 15, to 691 in October 15 to September 16 to 694 in October 16 to September 17. As the data clearly indicates, there is an increasing trend of non-compliance, and therefore the pharma industry needs to improve its compliance. This can be achieved through building a culture of quality in company. A strong quality culture is best indicated by what is done when nobody is looking. Management support, robust quality system and effective training are required to have compliance to quality. Establishing a quality culture is a challenging undertaking for any organisation. It is even more challenging to maintain it over time.
In order to maintain a quality culture, organisations must foster the following behaviour:
- Maintain an awareness of quality as a key cultural issue
- Make sure that there is plenty of evidence of the management’s leadership
- Empower employees and encourage self-development and self-initiative
- Recognise and reward the behaviours that tend to nurture and maintain a quality culture
We have seen that many organisations have benefited due to quality culture trainings and changing their mindset and attitudes drastically. The quality culture can be built or improved through various aspects which are classified into non-technical and technical.
Non-technical aspects of culture
Non-technical aspects of cultures are related to human personalities and company management.
- Attitude: This is foremost important factor for building a quality culture. Everyone should have a positive attitude towards quality management. Many companies aim to meet defined quality parameters by regulatory which lead to ignorance of some of critical aspects. Hence, the company needs to use guidelines/specifications given by regulators as guiding principles and work on further refining of quality aspects which are product specific. Many are under the false impression that by meeting regulatory specifications/ guidelines, product failure (due to quality, efficacy and safety) is the responsibility of the regulator. This perception needs to be changed.
- Resources: The management needs to provide adequate resources to perform product lifecycle management. This includes quality manpower, materials and machines.
- Timeline: The management / senior executive team needs to provide adequate and achievable timeline to perform various activities in the product life cycle.
- Human behaviour: The company needs to build a culture of total transparency in operation. There should be an open culture to express and debate various challenges faced by cross functions. In many places, the management thinks that once a competent head is appointed, they are free of looking down the line. On the contrary, the management shall ensure themselves that front line persons are working efficiently and with ease. Any issues/concerns at the front level work will lead to serious non-compliances.
- Blame game: In many companies, it is observed that quality compliance is the responsibility of the quality assurance (QA) department only. If there is any failure, they are directly responsible. This perception need to be changed as quality compliance is the responsibility of all persons in the organisation, from the sweeper to the top management.
- Budgeting: Provisions for expenses are important at all stages of product life cycle. Effective and micro-level budgeting can lead to minimal non-compliances. Lack of adequate budgeting leads to cut short at many places which can lead to non-compliances. Many time total failures.
- Planning: Adequate planning is very important to support product life cycle. Fail to plan is planning for failure.
Technical aspects of culture
There are many technical aspects which lead to quality management, but here we discuss a few critical ones frequently cited by the US FDA in their observations.
- Job responsibilities: It is a frequent observation that the job responsibility mentioned is very high level / vague and there is scope for ambiguity which leads to failure in compliance. Each person’s job responsibility (from the cleaner to the management) shall be defined in great detail. This will help reduce the gap between job profile and identification of a person’s skill and qualifications.
- Job training: It is necessary to identify the gap between job responsibilities and a person’s qualification and skills. Accordingly, the necessary training is to be provided. Also, there are frequent updates in regulatory requirements which lead to on-job training of personnel by subject experts.
- Product development: Regulators have provided a well-defined approach for product development. For example, Quality by Design, PAT. This needs to be implemented in depth and ease.
- Technical tools: There are various technical tools suggested by regulators which need to be implemented. For example, QTPP (Quality Target Product Profile), Critical Quality Attributes (CQA), Critical Process Parameters (CPP), Quality Risk Management, Failure Mode Effect Analysis (FMEA), Corrective Action Preventive Action (CAPA), Change Control (CC), Annual Product Review, eCTD for regulatory submissions, eDMS [Electronic Document Management System] etc.
- Documentation: This is the major reason for non-compliances. There are either no documentations or poorly arranged/defined documents. The main reasons to improve on this – job-specific skill sets are not available, inadequate on-job training, lack of resources (manpower, machine, materials).
Below are key failures:
i. SOPs are not well defined or followed
ii. Specifications and procedures are inadequate in manufacturing and testing
iii. No validations and qualifications are performed or their main objectives are not attained
iv. Investigation reports are incomplete or not adequate
v. Technical writing and review skills are not taken into account
vi. Training on different tools and practice or hands-on