10 Best Practices for GMP in Pharmaceutical Manufacturing!

As a part of the Good Manufacturing Practices in pharma industry, what steps are compulsory for you? And which practices of GMP Certification are best for your pharma company?

Learn all these things with this blog.

All knows that the pharmaceutical industry is essential for any country. The sector pharmacy is related to medicines, health, and medical devices, due to which it becomes a sensitive part. Making sure about the safety and quality of medicines and medical devices has also become a compulsory step for any authority. Then, in that case, the GMP certification plays its role by ensuring safety and quality in the pharmaceutical industry. GMP provides them with guidelines and regulations that they have to follow in their manufacturing facility.

Good manufacturing practices certification provides the pharma-related companies with an image and reputation that the products are made under strict GMP regulations with high-quality materials. The GMP best practices for pharmaceutical companies include following robust quality controls, maintaining documents, checking all your processes, training your employees, maintaining your facility, conducting regular audits for compliance, and maintaining cleanliness etc. These are some best practices that Good Manufacturing Practices provide to pharma industry, and how pharma manufacturers maintain GMP standards? 

1. The 10 Best GMP Practices are Explained Briefly for the Pharma Sector

The authority of GMP provides some practices that pharma manufacturers have to follow in their production units. These practices help the founders and manufacturers know about their company and also help them in maintaining proper cleanliness and guidelines in their production unit. The certification of GMP is provided by some authorities in different countries like, FDA, the WHO, etc. And these authorities offer some guidelines and practices for the companies that are related to the pharmaceutical, food, and health sectors.

Do Pharma and Food Industries Need GMP Certification? Find Out Why

The top 10 best practices that GMP provides to pharmaceutical companies are mentioned below:

1. Create and implement Standard Operating Procedures (SOPs)

The first practice includes providing detailed SOPs which you have to include all critical processes to ensure consistency and a standardized workflow.

Make sure that your employees and workers in your production unit are properly trained and strictly adhere to all regulations.

2. Maintains and provides documentation and recordkeeping

Provides all the related documents, which include all procedures, processes, and results, and ensures they have master formulas, batch records, and equipment logs.

Always maintain a record-keeping system in your production unit that is clear, complete, and traceable, and also follow ALCOA+ principles.

3. Check your processes and equipment

In your production unit, check that all of your processes are fully maintained for achieving their intended results.

Maintain and check all of your equipment in terms of ensuring that they are working properly and reliably.

4. Train your employees and hygiene

Also, make sure that all the employees and workers of your production unit know about their roles and responsibilities.

For that, provide them with some training under GMP principles, specific procedures, and hygiene standards, so that they maintain proper cleanliness in your facility.

5. Make your facility proper

Make your facility’s design proper, due to it prevents contamination and errors, to make a clean and suitable production environment.

Also, ensure a systematic environment plan that helps your facility and equipment maintain functionality and cleanliness.

6. Creates a Quality Management System (QMS)

Create, or we can say establish a QMS, which properly covers all of your processes within your production unit and quality in every workflow.

Make sure that the system of your unit ensures change control, managing deviations, and implementing corrective and preventative actions (CAPA).

7. Handle your raw materials and products

Create some strict controls on your raw materials, which are provided by the supplier. Also, check that the raw material is fully tested and safe with a receipt, in case of quality and suitability.

8. Stay away from contamination

Make cleanliness your priority, also maintain good hygiene in your production unit to prevent contamination in your products at all stages of manufacturing.

This includes environmental monitoring, mainly for sterile products.

9. Ensure quality and integration

Instead of considering quality as a distinct function, develop a standard-oriented mindset across your entire firm.

Make a checklist of quality checks and controls in your full production workflow in terms of ensuring quality is maintained in your products, not just a test.

10. Make sure of regular audits

Ensure that you are doing regular internal and external audits to ensure compliance with GMP protocols.

You can also use these audits for identifying related gaps in your system and bringing consistent improvement.  

2. Process of GMP for the Pharma Sector in 10 Easy Steps

Now you know about the 10 best practices that the pharmaceutical GMP compliance guide provides to the manufacturer related to the Good Manufacturing Practices in pharma industry. In this paragraph, you will learn about the process of GMP certification in 10 simple steps, which helps you in getting your GMP certification if you have issues getting it.

The 10 easy and simple steps for follows:

1. Firstly, review and understand the guidelines of GMP, which perfectly fit in your industry, and then conduct a gap analysis in your facility.
2. Then create and implement a robust QMS that includes a system that controls internal audits and manages deviations and corrective actions.
3. Creates clear and detailed Standard Operating Procedures (SOPs) of every step of your unit for ensuring everything is documented, followed, and validated.
4. Then, train your staff according to GMP regulations and ensure they understand their roles, responsibilities.
5. Getting your certification also ensures that your production unit is properly designed, maintained, and cleaned to prevent contamination.
6. Establish a system to confirm the quality and traceability of all production-related materials, from raw materials to final products.
7. Create a perfect record of all manufacturing, testing, and distribution activities happening in your facility. Because documentation is important for the GMP Certificate Online.
8. Then go for some regular self-inspections or internal audits to ensure adherence to compliance and identify areas for improvement.
9. Then, after all of these steps, search for and choose an authorized body to which you provide your request and to whom you schedule an official inspection of your unit.
10. Finally, a certification body will conduct an on-site audit to verify that your facility and the processes that are included are complying with GMP regulations. And be prepared for taking the best actions that are necessary.

Some facts on GMP’s practices and regulations:

1. Did you know: The GMP certification is the only certification that ensures safety and quality in your production unit, also.
2. Did you know: The certification of GMP takes the longest time to provide you with the certification for your facility.
3. Did you know: This certification is only applicable for manufacturers that are related to pharma, food, and health-related sectors.

3. For your Good Manufacturing Practices Pharma Industry, Get Your GMP with LegalRaasta!

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