Join Us

Your Name:(required)

Your Password:(required)

Join Us

Your Name:(required)

Your Email:(required)

Your Message :

0/2000

5 Things to Know Before Buying GMP Manufacturer

Author: CC

May. 19, 2025

21 0

7 Things to Know Before Your First GMP/GAMP Project | DMC, Inc.

GMP stands for good manufacturing practices. GAMP is good automated manufacturing practices. All manufacturing endeavors benefit from attention to quality, but this is especially important when the product is pharmaceutical. As a literal matter of life and death, following GMP for pharmaceutical manufacturing is not just good sense, but also the law.

You will get efficient and thoughtful service from Lianhe Aigen.

However, it's not always obvious where to start. Here are seven things you should know about GMP.

1. The FDA Sets the Rules

That's the federal Food and Drug Administration, which is a government agency funded by taxpayers, and charged with protecting and promoting public health. The FDA publicly publishes official guidance, and these guidelines have the force of law. Violating FDA guidelines bear criminal consequences.

2. ISPE is the Go-To for Guidelines

The International Society of Pharmaceutical Engineers is the foremost authority on how to achieve FDA regulations. One does not have to follow ISPE recommendations to achieve good manufacturing practices, but one of the most straightforward ways to guarantee FDA compliance is to follow ISPE recommendations. ISPE publishes these guidelines in print and on the web for a thorough variety of applications. Time saved vs. time spent developing and refining an original solution easily covers the cost of these publications.

3. There is No "Best" Practice

There is no "best" because every application is different. Federal guidelines are open-ended and emphasize responsibility, ownership, and traceability. The guidelines aren't step-by-step, but the approach that a company develops to meet them should be.

4. GAMP = User Accounts & Audit Trail

There are no specific programming practices required by the FDA. General, good practice is recommended -- like separation of concerns, using comments to explain the "why" of the code, using appropriate architectures like state machines, etc.

The only specific requirements relate to Electronic Records -- e.g., recipe databases or process data archives. The FDA guidance document CFR Part 11 describes electronic records requirements.

The key to compliance is: limit access, track all changes, and attribute all changes to certain users.

To accomplish this, the general approach is to limit all edit-access to only users with accounts. Accounts must be associated with a user's full name, and users must not share accounts. All changes are timestamped and bear the identity of the person who made the change; that's their "e-signature". The original record is always saved somewhere, and never destroyed -- that's the "audit trail" part.

Siemens, Rockwell, and other PLC/HMI providers have whole suites of built-in features for CFR Part 11 compliance.

5. The C Stands for Current

cGMP stands for current good manufacturing practices. "Current" is important, because the cutting-edge way to do something 5 years ago may now be obsolete. It's important to keep evaluating your process to make sure it meets current good practice.

6. You Don't Have to Reinvent the Wheel

Implementing GMP can be quite the undertaking, so there's lots of room for agencies and companies to provide a value add. When considering a solution, it's good to know that you can buy:

  • Consulting services - Some companies will provide both expertise and labor to get your manufacturing process up, running, and compliant
  • Requirements tracking - Some of these are explicitly for GMP, others are more generic, but these softwares take a lot of the headache out of managing requirements and traceability for large projects (more on that below)
  • Audit trail & e-signature software - When it comes to automation and digital data storage, the key to compliance is a data audit trail with an electronic signature, as mentioned in item 4 above. Turning on audit trail with a checkbox or two is a significant value add over building the functionality in-house.

7. Documentation is Key

Documentation helps to unite an effort across stakeholders and across time.

When there are multiple stakeholders, the documentation serves as a central reference for what was required, and how it was accomplished. These teams may be in different parts of the world, but by writing down and confirming all assumptions and requirements, everyone can be on the same page (pun intended).

It takes months to implement a process that may run for years, so a more robust record is required than memory. Documentation takes effort, but it decreases future uncertainty. When an auditor asks how something is done, one can confidently say, "Here's the written procedure. It was completed on this date by this person."

Documentation is such a crucial part of the process that it received its own blog post, here! 

The company is the world’s best GMP Manufacturer supplier. We are your one-stop shop for all needs. Our staff are highly-specialized and will help you find the product you need.

Ultimately, the purpose of good manufacturing practices -- and good anything practices (aka GxP) -- is to promote safety and health through attention to quality.

What is GMP | Good Manufacturing Practices | SafetyCulture

What is the difference between GMP and cGMP?

Good Manufacturing Practices (GMP) and current Good Manufacturing Practices (cGMP) are, in most cases, interchangeable. GMP meaning the basic regulation promulgated by the US Food and Drug Administration (FDA) under the authority of the Federal Food, Drug, and Cosmetic Act to ensure that manufacturers are taking proactive steps to guarantee their products are safe and effective. cGMP, on the other hand, was implemented by the FDA to ensure continuous improvement in the approach of manufacturers to product quality. It implies a constant commitment to the highest available quality standards through the use of up-to-date systems and technologies.

What are the 5 Main Components of Good Manufacturing Practice?

It is paramount to the manufacturing industry to regulate GMP in the workplace to ensure consistent quality and safety of products. The five main components of GMP, commonly referred to as the 5P’s, help organizations comply with strict standards throughout the entire production process.

  1. People – All employees are expected to strictly adhere to manufacturing processes and regulations. A current GMP training must be undertaken by all employees to fully understand their roles and responsibilities. Assessing their performance helps boost their productivity, efficiency, and competency.
  2. Products –  All products must undergo constant testing, comparison, and quality assurance before distributing to consumers. Manufacturers should ensure that primary materials including raw products and other components have clear specifications at every phase of production. The standard method must be observed for packing, testing, and allocating sample products.
  3. Processes – Processes should be properly documented, clear, consistent, and distributed to all employees. Regular evaluation should be conducted to ensure all employees are complying with the current processes and are meeting the required standards of the organization.
  4. Procedures – A procedure is a set of guidelines for undertaking a critical process or part of a process to achieve a consistent result. It must be laid out to all employees and followed consistently. Any deviation from the standard procedure should be reported immediately and investigated.
  5. Premises – Premises should promote cleanliness at all times to avoid cross-contamination, accidents, or even fatalities. All equipment should be placed or stored properly and calibrated regularly to ensure they are fit for the purpose of producing consistent results to prevent the risk of equipment failure.

What are the 10 Principles of GMP?

  1. Create Standard Operating Procedures (SOPs)
  2. Enforce / Implement SOPs and work instructions
  3. Document procedures and processes
  4. Validate the effectiveness of SOPs
  5. Design and use working systems
  6. Maintain systems, facilities, and equipment
  7. Develop job competence of workers
  8. Prevent contamination through cleanliness
  9. Prioritize quality and integrate into workflow
  10. Conduct GMP audits regularly

Further information can be found at this PDF Guide to GMP: Good Manufacturing Practices.

GMP Regulations

GMP regulations are mandated by manufacturers’ respective national governments to regulate the production, verification, and validation of manufactured products and ensure that they are effective and safe for market distribution.

For example, in the United States, GMP is enforced by the US FDA through Current Good Manufacturing Practices (CGMP) which cover a broader range of industries such as cosmetics, food, medical devices, and prescription drugs. The FDA conducts facility inspections to assess if a manufacturing company complies with CGMP regulations. If any serious violations are found during the inspection, FDA recalls all products, which is problematic for manufacturers in terms of both profit and business operations.

The quality of manufactured products is highly regulated as it can pose negative health risks to consumers and even the environment. Poor hygiene, temperature-control, cross-contamination, and adulteration in any step of the manufacturing process are some examples of how a manufactured product that doesn’t follow GMP regulations can bring fatal consequences to consumers. See GMP regulation and preamble sources by country here.

GMP Standards

GMP standards are developed to enhance the safety of manufactured products, especially pharmaceutical goods, and to ensure consumers get the highest quality possible. Adherence to GMP standards not only positively impacts the reputation of manufacturing companies but also reduces batch recalls and negative reports from consumers. Below are 4 measures you can follow to uphold GMP standards:

Quality team

Have a team of skilled workers that will focus on improving current manufacturing procedures and complying with GMP. Members will perform quality assessments on operations to identify problems and develop appropriate corrective measures. Part of the team’s responsibility will also be performing scheduled monitoring of instruments, equipment, processes, and staff skills.

Validation

Validation is the documented act of demonstrating instruments, processes, and activities that are regularly used or done. This is done to check if they function according to expectations. GMP can involve a number of things to be validated, but it’s good to focus on the following processes:

  • Process validation
  • Cleaning and sanitation validation
  • Computer system validation
  • Analytical method validation

Surprise Audits

A surprise audit every now and then can help gain a more accurate insight into what goes on in the facility. Identify real root causes of non-compliance and take action before it progresses into a larger issue. Read more about best practices in doing GMP audits.

Compliance Training

Providing compliance training to staff is the best way to ensure compliance with GMP standards. Help staff gain a better understanding of GMP and continually improve operations or systems in place to ensure standards are GMP-compliant. All employees should receive training on recordkeeping, sanitation, proper equipment handling, and labeling, and SOPs to minimize errors and maintain compliance.

Create your own GMP Audit Checklist

Build from scratch or choose from our collection of free, ready-to-download, and customizable templates.

How to Comply with Guidelines

GMP guidelines and regulations address different issues that can influence the safety and quality of a product. Meeting GMP or cGMP standards helps the organization comply with legislative orders, increase the quality of their products, improve customer satisfaction, increase sales, and earn a profitable return on investment.

A GMP audit helps improve the overall performance of different systems including the following:

  • Building and facilities
  • Materials management
  • Quality control systems
  • Manufacturing
  • Packaging and identification labeling
  • Quality management systems
  • Personnel and GMP training
  • Purchasing
  • Customer service

Ensure Compliance with Manufacturing Regulations

Simplify internal audits, capture site observations, and address gaps in compliance to meet regulatory requirements.

GMP Training

We’ve curated a list of GMP training courses that will guide your employees in following GMP standards so they can be proactive in minimizing risks in all aspects of manufacturing products such as food, cosmetics, and pharmaceutical goods. These courses cover topics such as good manufacturing practices, quality control, risk management, and many more.

Contact us to discuss your requirements of Drug Substance CDMO Service. Our experienced sales team can help you identify the options that best suit your needs.

Customer Story

Comments

0/2000

Guest Posts

If you are interested in sending in a Guest Blogger Submission,welcome to write for us!

Your Name: (required)

Your Email: (required)

Subject

Your Message: (required)

0/2000