- What Is Good Manufacturing Practice Part 1
- Importance of GMP Part 2
- 4 Essential Principles and Elements of GMP Part 3
- GMP Best Practices Part 4
What Is Good Manufacturing Practice?
Good Manufacturing Practice is a regulatory system whose main aim is to uphold consistency and safety during the production process. Commonly known as GMP, this procedure predominantly capitalizes on key aspects of the whole manufacturing process like:
- Procedures employed during production
- The competence of your staff members
- The basic design of the facilities used in the manufacturing process
- Hygienic conditions of the environment where the products are being manufactured
Good manufacturing practices look forward to precisely evaluate all the procedures your company involves in well as the qualification level of the employees tasked with the manufacturing process.
Generally, a typical good manufacturing practice comprises of dozens of precautionary guidelines that factory/company owners as well are obligated to adhere to.
By observing these standard recommendations, your organization will be able to precisely monitor all the procedures employed, the specific employees involved as well as the conditions of production.
Besides boosting product safety, GMP provides an excellent documentation procedure that greatly enhances follow-ups in case substandard or unsafe products.
Importance of GMP
First and foremost, an excellent GMP culture necessitates meticulous documentation of all the production workflow. Besides enabling you to precisely monitor all the adherence of your employees to the manufacturing guidelines, step by step recording provides a comprehensive document which is later customized for legal purposes. While making and maintaining peace with the law is essential for the legal operation of your corporate, GMP yields dozens of other benefits which include:
- Forms an exquisite avenue for quality control
- Promotes hygiene in the manufacturing process
- Enhances quality assurance through evaluating the competence level of your workforce
- Ensures suitable manufacturing facilities and equipment through regular maintenance checkups
- Through meticulous documentation, GMP allows effortless traceability in case of a production problem like product contamination
- Helps you build an outstanding reputation that distinguishes you from your competitors
Essential Principles and Elements of Good Manufacturing Practices
Here are some of the most essential aspects of successful Good Manufacturing Practice:
Document All Your Procedures
Whether a simple straightforward procedure or an intricate workflow that involves multiple stages, all manufacturing processes need to be meticulously documented down to the very fine details.
This provides an intuitive roadmap across the entire manufacturing process.
With an excellent view of the procedures employed, you will be able to effortlessly identify vital commonly overlooked steps which greatly contribute to the overall quality and safety of the final product.
Besides that, perfectly documenting all your manufacturing procedures enables you to seamlessly monitor each step of the entire production process which ultimately ensures consistency across all your merchandise.
Always Adhere to the Recommended Manufacturing Instructions
Whether a knowing or an innocent move, any careless mistake in the manufacturing process may end up putting your company and the life of your consumers on the line. Essentially altering the production guidelines may contaminate your entire production line consequently compromise the quality of the final products. For that reason, it is always important to follow all the manufacturing instructions to the letter.
Frequent Equipment and Facility Checkups
System failure is one of the major causes of contamination in most organizations especially the ones that deal with highly sensitive products like foods and pharmaceuticals. While negligence and ignorance are some of the reasons why most production equipment fails, a business organization that upholds Good Manufacturing Practices should constantly evaluate the working conditions of their systems.
Generally, an excellent system maintenance exercise should be incredibly comprehensive where service technicians develop insightful notes.
When conducting equipment checkups consider referencing from the manufacturer’s menu.
It is vital to first to conduct a detailed proof of concept analysis before initiating large scale manufacturing.
To do this, carefully follow your procedures on a sample product and once done conduct multiple quality and consistency tests.
Other Key Elements of Good Manufacturing Practices Include:
- Evaluating workforce competence
- Avoiding both primary and secondary contamination
- Conducting frequent GMP audits
Best Practices to Ensure Good Manufacturing Practices
To enjoy the maximum benefits of observing the principles of good manufacturing practices here are some of the dos and don’ts to consider:
- Written procedures should be professionally drafted in a simple clear and easy to understand tone. Avoid providing vague guidelines that may be hard for your employees to comprehend thus confusing them.
- To achieve better and more improved results, altering the manufacturing guidelines is inevitable. As much as this is imperative for the growth of your venture, it is important to validate the feasibility/workability of the updated procedure before employing it on a large scale perspective.
- Predominantly, especially when dealing with sensitive products that are prone to contaminations like pharmaceuticals, consider using the recommended design of the facilities and equipment during manufacturing. Generally, this will greatly reduce human error as well as secondary contamination.
Other Best Practices Are:
- Acquit yourself with the relevant regulatory authorities to precisely understand the allowed tolerance level.
- Equipment maintenance should be as per the manufacturer’s instructions.
- Before hiring employees in any position, it is important to conduct a detailed competence analysis.
- Constant good manufacturing audit is essential. Typically, this should be on monthly basis.
- Only use approved manufacturing procedures. If you are not sure about something, outsource advice from an expert.