Good manufacturing practice (GMP) is a regulatory framework that governs the manufacture, including packaging, of pharmaceuticals, food, and health foods. This includes rules regarding staff training and responsibilities. These rules were developed to ensure that the quality of the medicine is high, and the integrity is maintained as intended. The Medical Products Agency is the authority that checks that regulations are applied in operations. Source: wikipedia
a collective understanding and a continous learning
It´s important to have a collective understanding of the shared responsibility we have as a manufacturer of packaging machines. There are a lot of restrictions in the pharmaceutical business, understanding this makes us a better machine developer and business partner. Therefore we continuously educate and reminds our co-workers about what good manufacturing practice means – to enhance the learnings and the discussions we connect theory with a recent customer cases.
In the role of being a supplier of products to manufacturers in the pharmaceutical industry, we not only ease pharmaceutical research and development, manufacturing, and accessibility of medicine. We also provide the industry with solutions that prevent human injury caused by quality issues or illegal actors.
Fredrik Gustavsson Chief Engineer and System engineer manager at Graniten:
The key to success
Changing perspective, putting on the customer glasses, swopping shoes or “go over the bridge to the other side” – beloved child has many names.
“The clue with GMP is to understand the customer’s point of view and always keep this in mind while asking the right questions” says Fredrik.
Now we have given you the key to success and you can skip investing in a course on the subject. However, GMP documentation can be 10 cm (about 3.94 inch) thick in printed paper. It can be written with many abbreviations and based upon local laws.
During our latest workshop, that was held by Helena Roth at Respondi, we learned everything from which directives to read depending on the type of market, to how and what to document correctly to ensure traceability and what specifications different tests audit.
6 handy tips for a good manufacturing practise
TIP 1: Set up a routine for how you will keep track of business insights and updates on the subject in a structured way.
TIP 2: Clarify who is in charge of keeping track on the different directives and in which forum they can share updates and new insights.
TIP 3: Take the time to help your potential customer to make a well-defined requirement list in an early stage. This is best done by a system engineer or another expert within the organization.
Tip 4: Make sure that you understand all the requirements the customer makes and why they make them. Ask many questions.
Tip 5: The user requirement specification is, to some extent, negotiable and possible to adjust along the product development process.
Tip 6: The IQ/OQ/PQ is something that the customer actually handles – but why not help them?
So, how do you take the next step when you want to level up your GMP knowledge even more Fredrik?
“The next step as I see it is to find your own company approach on the GMP matter. At Graniten for example we are experts on innovation, so we can only find more ideas in GMP requirements since the requirements may dictate us the “what” but never the “how”.
To get you started – here’s a list of abbreviations connected to GMP
- DFA = Design for Assembly
- DFM = Design for Manufacturing
- DS = Design Specification
- EBIT = Earnings Before Interests and Tax
- FAT: Factory Acceptance Test
- FDA = Food and Drug Administration
- FMEA = Failure Mode and Effect Analysis
- FS = Functional Specification
- GMP: Good manufacturing practice
- OQ: Operational qualification
- IQ: Installation qualification
- LES = Line Execution System
- MSS = Market Segment Specification
- MVP = Minimum Viable Product
- NDA = Non-Disclosure Agreement
- OEE = Overall Equipment Effectiveness
- POC = Proof of Concept
- PQ: Performance qualification
- RASIC = Responsible, Approve, Support, Inform, Consult
- RCT = Request for Cost and Timing
- RFQ = Request for Quote
- SAT: Site Acceptance Tests
- URS = User Requirement Specification
good manufacturing questions to start off with:
It’s basically about knowing WHAT the customer need and WHY.
So, any question that helps to clarify it is definitely desirable. Therefore, make sure that you understand all the requirements the customer makes and why they make them.
What are your needs?
What are the risks in the part of the process that we intend to assist you with?
And by all means ask them to tell you about the product and its conditions, so that YOU understand where in the chain you come in.
Graniten is a global provider of machine solutions to the pharmaceutical manufacturing and healthcare automation sector.
At Graniten, the core purpose is to empower customers and help them improve their production and workflow to continuously improve patient care and security.
The aim is to become a business leader in technical solutions & innovations within the scope of manufacturing and engineering and achieve:
- Staying ahead of industry challenges and customer needs and creating user-centric solutions
- Leveraging creativity and implementing new innovative technologies
- Limiting environmental impacts through optimization, sustainability, and small footprint products