Principles are fundamental norms, rules, or values that represent what is desirable and positive for a person, group, organisation or community, and help it in determining the rightfulness or wrongfulness of its actions. Principles are more basic than policy and objectives and are meant to govern both. So, then, a principle is an accepted or professed rule of action or conduct, or a basic idea or rule that explains or controls how something happens or works
Good Manufacturing Practice
Good Manufacturing Practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimise the risks involved in any food, cosmetic or pharmaceutical production that cannot be eliminated through testing the final product.
In order to produce safe and quality products, one must follow good manufacturing practices. The food and pharmaceutical business has a legal and moral responsibility to produce food and drugs which will not harm the consumer. Today, many factories are situated in areas which do not fit into the manufacturing framework. The environment within which food and pharmaceutical businesses need to be established must have certain basic characteristics. The Public Health Act, 2012 (Act 851) is explicit on the siting of manufacturing establishments, especially food and by extension pharmaceutical and water-packing businesses.
There are certain conditions that must be met before the Food and Drugs Authority can licence premises for the above-mentioned sectors – so that before GMP is invoked these conditions must be fulfilled. Let’s look at a few.
A manufacturing establishment for the purpose of producing food, packaged water, pharmaceutical products and even a restaurant shall not be sited in dusty and flood-prone areas. They should not also be sited close to public toilets and refuse dumps. For good manufacturing practices to work, these basic parameters need to be taken care of. This article will look briefly at the 10 principles of good manufacturing practices and reserve the details of each principle for subsequent articles.
GMP Principle 1: Writing step-by-step operating procedures and work instructions
Every manufacturing company has a set of guidance documents which help it achieve its objectives in terms of product output and ultimately satisfying customers. The first principle of good manufacturing practice takes cognisance of the fact that work procedures and work instructions are basic to the business’s operations. Hence, it is important to write all procedures, right from the beginning of the process to the end.
GMP Principle 2: Following written procedures and instructions
In my auditing experience of the quality, food safety, health & safety and environment, I have come across many organisations who’ve invested in writing all documents pertaining to work procedures. The biggest issue has got to do with following the written procedures so documented. In many cases, you’ll find employees employing procedures quite different from what has been documented.
GMP Principle 3: Documenting our work
What is it about recording the outcomes of our work that is so difficult? Yet documenting the work we do is one of the major headaches facing personnel in organisations. Yet again, in my auditing experience I’ve come across record-keeping challenges. Once I spoke to an operator as to why he was not recording certain process parameters as he worked. He wanted to finish working and fill the record sheets after his shift ended. The question is: how was this employee going to recollect all the parameters after 8 hours of work? It was not surprising when production records from six months earlier revealed blank spaces!
GMP Principle 4: Validating our work
It is always important to ascertain whether when certain activities are undertaken on the production floor and given a certain set of results, such results are actually accurate. Our work needs validation; normally by using other methods to cross-check results. That’s the only way to ensure confidence in our systems and processes.
GMP Principle 5: Designing and constructing facilities and equipment
Depending on the nature of product being manufactured, there are hygienic design-protocols that need to be followed. The design of process vessels for the dairy industry is definitely going to be different from other products, although some design protocols run through the food industry without exception. For food and pharmaceutical production floors, there could be zoning: low-risk, medium-risk and high-risk areas. Each zone has its own set of standards, all in a bid to avoid contamination risks.
GMP Principle 6: Maintaining facilities and equipment
When it comes to facility and equipment maintenance, there is a huge gap in organisations. The issue cuts across the private sector and government establishments alike. Lack of equipment maintenance exposes consumers to several hazards. Remember, the aim of the manufacturer should always be product safety and quality. It is quite common to see paint flaking in restaurant kitchens, exposing cooked food to physical as well as chemical hazards. In some manufacturing sites, the amount of rust on equipment can be quite scary.
GMP Principle 7: Defining, developing and demonstrating job-competence
One of the issues confronting industry is putting square pegs into round holes. Every job should be well-defined before the recruitment process. Competent people should be employed to manage processes in the establishment. It is also important to upgrade the skills of existing workers – especially when new technologies emerge. Each organisation must have a way of evaluating personnel on the job to ensure they keep to quality standards in their respective areas of work.
GMP Principle 8: Protection against contamination
For the food, water and pharmaceutical industries, contamination of the process environment, including equipment, compromises whatever product is being produced. It is important to ensure that all activities geared toward contamination prevention are taken seriously. Cleaning, disinfection and decontamination processes must be undertaken with a level of importance. Consumer protection should be at the forefront of every discussion in any manufacturing establishment.
GMP Principle 9: Controlling components and product-related processes
All products go through a set of processes before the final product comes out at the end of the product line. The effective control of such processes is key to the outcome of the final product. For instance, if pasteurisation temperatures are not managed according to the standard, there is always a possibility of packing products that will eventually affect the safety of consumers. The importance of having firm supervision of process parameters cannot be over-emphasised.
GMP Principle 10: Conducting planned and periodic audits
As defined in ISO 19011:2011—Guidelines for auditing management systems, an audit is a “systematic, independent and documented process for obtaining audit evidence [records, statements of fact or other information which is relevant and verifiable] and evaluating it objectively to determine the extent to which the audit criteria [set of policies, procedures or requirements] are fulfilled”. Several audit methods may be employed to achieve the audit purpose. Audits must be conducted at periodic intervals, such that nothing will be missed. Since auditing is an improvement exercise, it must be encouraged across the organisation.
From the above, it is clear that industry players cannot work without consulting the relevant GMP principles and putting these into practice. In the coming weeks, we will be taking each principle and delving deeper for better understanding. Following product-specific GMPs is the way to go in ensuring the safety of consumers is preserved.
Johnson Opoku-Boateng is the Chief Executive & Lead Consultant, QA CONSULT (Consultants and Trainers in Quality Assurance, Health & Safety, Environmental Management systems, Manufacturing Excellence and Food Safety). He is also a consumer safety advocate and helps businesses with regulatory affairs. He can be reached on +233209996002, email: [email protected].
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