In every company, it is the duty of every person involved in the manufacturing process to ensure that the end products are both safe and of the highest quality. Good manufacturing practices are established government regulations that are used to ensure this.
If you’ll like to have an overview of what Good Manufacturing Practices (GMP) is all about, kindly check out the post on The Ultimate Guide to an Introduction in GMP. In this post, our focus will lie on ten proven tips to enable your company to exercise good manufacturing practices.
Start with the Right Facility Design
One of the major problem companies face is constructing a subpar facility most due to inadequate planning. It is quite difficult to keep good manufacturing practices in a poorly constructed facility. For instance, a poor layout can increase unnecessary traffic on the production floor. Sadly, correcting such design errors is usually cost intensive.
Therefore, it pays to take the time to critically design the facility before construction commences. The layout must be taken into consideration to prevent unnecessary traffic or contamination. The environmental factors – like lighting, temperature, pressure, etc. – must be taken into cognizance when planning the design. Finally, the equipment must be adequately positioned to ensure easy usage and maintenance.
Procedures and Instructions Should Be Well-written and Adhered to
Imagine a company without a procedure to carry out tasks. In such a scenario, newer employees have to look up to older ones for guidance and instruction. If you’re a bag producing company, that may be fine. However, such a chance cannot be taken if you’re a drug or food company. Therefore, procedures should be laid out in a lucid, precise and logical order.
Specifications, operating instructions, operating procedures and records much be easily accessible to concerned employees. Furthermore, systems must be put in place to ensure that people adhere to the procedures. Taking of shortcuts (not stated in the procedures), without taking prior permission from superiors should be frowned at.
Good Documentation Must Be Kept Accurately and Promptly
Good Documentation will allow you to keep track of the manufacturing process; from receipt of inventory, to actual production and to the distribution to final users. By keeping a good record of the activities, it becomes easy to validate processes and track if you’re keeping in line with the stated practices. All important information must be recorded in a neat and accurate fashion. To learn more about documentation, you can visit or post on GMP Documentation and Records.
Validate Your Processes
Validation is used to prove that a specified process will consistently produce a product that matches up to the pre-defined specification and quality level. It involves a series of tests to provide a high assurance that the process will work in the pre-determined fashion. Validation is usually required for the equipment installation, operational processes, and performance. If any change is made to a system, a revalidation is invariably required to ensure that consistent high-quality products are produced.
Ensure That Roles are Properly Defined
When employees don’t know what their daily task is, misunderstanding is bound to ensue. Such misunderstandings can have a detrimental effect on product quality. Therefore, the job responsibility for every employee must be unequivocally stated.
Furthermore, an organizational chart should be created to show the hierarchy in the company. This way, everyone knows what is expected of them and also who to report to if they have any complaint.
Investment in the Development of Employees
In order to keep good manufacturing practice, you need the right people. It is your responsibility to ensure that your employees have the requisite skill-set that is required for them to perform their job excellently. General and Job-specific training should be organized for employees to show them how to execute their job effectively and in accordance with GMP. Furthermore, staffs should be held accountable for demonstrating their competence. This can be derived from analyzing key performance indicators.
Practice Proper Sanitation
The risk of contamination must be reduced to the barest minimum on a manufacturing site. Keeping a proper hygiene through sanitation programs is an effective way to ensure that. Similarly, cleaning standard for various processes must be defined. For instance, the standard for sterile surgical equipment must be well defined. Furthermore, smoking should be prohibited on the manufacturing site.
Take Maintenance Seriously
Some companies try to boycott maintenance to maximize current profits. However, such a practice has a devasting impact on the long run; it can lead to product contamination and an eventual breakdown, which is usually costlier to fix. To avoid this, a proper maintenance record must be kept. This record will show when the equipment was last serviced and the next routine maintenance schedule. Most importantly, maintenance schedules for the equipment in the facility must be strictly adhered to.
Make High-Quality Your Watchword
Across all the facets of the lifecycle of the product, high quality must be maintained. This involves ensuring that the raw materials and equipment used meet-up the required specifications. Similarly, the manufacturing process must be controlled for quality. Furthermore, the packaging and labelling of products must be done adequately to avoid mix-ups. Finally, the end product must be stored and distributed in a matter that would not compromise the quality of the product.
Perform Regular Audits
External agencies like the FDA in the USA and TGA in Australia are required to carry out regular audits on companies. This is to ensure that they are adhering to good manufacturing practices. More importantly, in-house audits should be conducted in the different departments at least twice yearly. This will enable your company to know where you’re lacking and plan for the necessary actions to be taken.
Conclusion
Do these practices seem like a heavy burden that you would not be able to bear alone?
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