Compliance Manufacturing Operations Quality Control

5 Fundamental Steps to Ensure Product Safety and cGMP Manufacturing Compliance


Current Good Manufacturing Practice (cGMP) are regulatory guidelines used for pharmaceutical, medical, cosmetics, food, food supplements, and beverage products. These guidelines ensure that what the consumer receives is high quality, delivers on the intended use, is marketed appropriately, and most importantly, is safe.

The U.S. Food and Drug Administration (FDA) is authorized to carry out routine inspections to ensure an business operations align with cGMP guidelines as detailed in 21 CFR

To help you prepare for these inspections, in this FAT FINGER article we explain what the cGMP guidelines are, and how requirements have evolved over the years. We then run through 5 fundamental steps for cGMP compliance.

With that said, let’s jump straight to it!

  • What is GMP manufacturing (GMP vs cGMP)?
  • Why is cGMP manufacturing important?
  • 21 CFR: Understanding the cGMP guidelines and how they have evolved
  • 5 essential steps for cGMP compliance

What is GMP manufacturing (GMP vs cGMP)? 

Good Manufacturing Practice (GMP) refers to the regulations that ensure consistent product quality for pharmaceutical, medical device, biotechnology, dietary supplements, cosmetics, and food and beverage items. These regulations are enforced by the Food and Drug Administration (FDA).

GMP vs cGMP standards 

cGMP differs from GMP in the sense that this acronym incorporates the variable of time. The c stands for current, with cGMP meaning current Good Manufacturing Practice. With this difference, cGMP adheres to contemporary guidelines and recognizes that best practices are subject to change, as the latest developments make existing guidelines unfit for purpose. The FDA expects manufacturers to stay ahead and comply with these changes, to ensure their processes are current. For instance, a given system and/or item of equipment might have been unrivaled in design quality some 10-20 years ago, but because of technological progress, now does not meet modern standards.

In this sense, GMP differs from cGMP in the following key ways, as detailed by Simple QMS

  1. Quality: Both GMP and cGMP guidelines are built to maintain product quality. Yet with cGMP, there’s an extra process step that maintains quality according to the most recent regulation standards. This means manufacturing operations are in tune with the latest FDA developments. 
  2. Cost: Due to the extra work needed, cGMP is more expensive than its sister GMP process. Extra investments are needed for additional testing that sometimes requires funding for new technologies. 
  3. Current standards: GMP represents the minimum standard for your industry. As we know, cGMP adds to that minimum, to provide the most up-to-date standards.

By adhering to cGMP standards, manufacturers ensure the identity, strength, quality, and purity of a given product in industries where these attributes are vital for the safety of the consumer. cGMP guidelines ensure this by: 

  1. Establishing strong quality management systems, 
  2. Obtaining the appropriate raw materials, 
  3. Establishing robust operating procedures, 
  4. Detecting and investigating product quality deviations, 
  5. Maintaining reliable test laboratories and procedures.

Assuring the above prevents contamination of products, ingredient mix-ups, deviations, and other errors that could prove disastrous for the consumer, and of course the business in question.

Why is cGMP manufacturing important?


One of the most important attributes of cGMP to remember is this: cGMP builds quality into the design and manufacturing process at every step.

Meeting the above demands facilities to be in good condition, adequately maintained, calibrated, and supplied with up-to-date equipment. It also demands employees to be fully trained. 

In pharmaceutical, medical, cosmetic, food, and beverage industries, you’re dealing with products that are manufactured in batches. Checking quality would mean randomly withdrawing a statistically determined number of products from these batches for testing. This, however, imposes an additional cost, as the tested products are not suitable for the consumer. More importantly, random sampling still means that thousands of items remain untested. A much better approach is to build quality into the manufacturing processes. Hence cGMP ensures product quality by design.

21 CFR: Understanding the cGMP guidelines and how they have evolved 

You could say the FDA’s cGMP guidelines were spring boarded by the publication of the book titled The Jungle. In this book, Upton Sinclair wrote about the dismal standards in the Chicago meat packaging industry. The conditions in these workplaces were unsanitary to say the least. Meat was often from diseased animals and frequently rotten. It was also reported to contain the remains of poisoned rats and even the body parts of workers who had fallen into the machinery. Sinclair’s mission was to highlight miserable working conditions and impoverished, unhygienic operating systems.

Sinclair’s book had a major impact on the American public, and Congress soon passed the Pure Food and Drug Act in 1906. This meant for the first time, it was illegal to sell contaminated or adulterated food. Also, product marketing and labeling had to be truthful. Today, the term adulterated refers to any product not manufactured following GMP guidelines. 

Over the years, the Pure Food and Drug Act led to the creation of the FDA. In 1933, the FDA exhibited America’s Chamber of Horrors. This chamber included a weight loss drug that could cause death, hair removal treatment that caused baldness, eyelashes that blinded consumers, skin creams that caused mercury poisoning, and hair dyes that resulted in lead poisoning. 

Yet it wasn’t until a later incident, known as The Sulfathiazole Disaster, that the FDA called for a stringent lockdown of quality control systems to relevant industries, giving rise to GMPs. The Sulfathiazole Disaster occurred in 1941, and killed ~300 people due to the haphazard manufacturing practices of the Winthrop Chemical Company of New York. This pharmaceutical company marketed sulfathiazole tablets, which were contaminated with the sedative phenobarbital.

Over the years, these GMP manufacturing practices have been refined and are detailed in what is named as the CFR guidelines.

To give you a better understanding of how cGMP guidelines have evolved, we’ve detailed a brief GMP timeline below, adapted from the Compliance Leadership Series.

  • 1982: GMP introduces Tamper-Resistant Packaging regulations, making it illegal to tamper with packaged consumer products. 
  • 1983: A Guide to the Inspection of Computerized Systems in Drug Processing is introduced making computer and computer validation controls tighter.
  • 1987: Guidelines are introduced detailing expectations regarding the need for process validation. 
  • 1990: The Safe Medical Devices Act is introduced to ensure health care institutions investigate, document, and report serious events related to all medical devices. 
  • 1992: Generic Drug Enforcement Act is introduced for a thorough and systematic drug approval process. 
  • 1996: The U.S. cGMPs for Drugs and Biologics (21 CFR 210-211) is revised and updated.
  • 1997: cGMPs for medical devices (Quality System Regulation) is revised to include current good manufacturing practices.
  • 1997: The Electronics Records Final Rule (21 CFR 11) is developed that requires controls that ensure the security and integrity of electronic data.
  • 1999: The FDA introduces a new technique for inspecting device companies, focusing on management controls, design controls, production and process controls, and corrective and preventive action.
  • 2001: GMP for Active Pharmaceutical Ingredients (APIs) is adopted by the United States, Europe, and Japan.
  • 2002: The FDA introduces a new technique for routine drug manufacturing inspections. Systems included in these inspections include facilities and equipment, materials, production, packaging, labeling, quality, and laboratory controls.

Today the regulations that govern cGMP compliance for most businesses are: 

  1. FDA approval for marketing new drugs using the 21 CFR Part 314 guidelines.
  2. Best practice for the manufacturing, processing, packaging, and holding of drugs with the 21 CFR Part 210
  3. 21 CFR Part 211 governs food and drugs within the United States for the FDA, the Drug Enforcement Administration (DEA), and the Office of National Drug Control Policy (ONDCP).
  4. 21 CFR Part 212 guidelines are introduced for Positron Emission Tomography (PET) drugs.
  5. 21 CFR Part 600 guidelines for general biological products are introduced.

5 essential steps for cGMP compliance

The FDA enforces cGMP regulations by monitoring the facilities, employees, and processes of manufacturers. As we’ve already mentioned, this means ensuring facilities are in good condition, that equipment is maintained and calibrated, that employees are qualified, and that manufacturing processes are both reliable and reproducible. 

There are a few basic requirements to fulfill to meet cGMP standards. We’ve detailed these requirements below for your review. 

cGMP compliance step #1: Document your manufacturing processes 

To be cGMP compliant, you need to be documenting your current manufacturing operations. cGMP standards are designed to detail scientifically sound methods, practices, and principles with the ultimate aim of delivering safe products. How would you know if you’re meeting these requirements without complete process transparency and traceability of development, manufacturing, and testing activities?

Adequate documentation will also provide auditors with the information they need to fully assess quality against cGMP guidelines.

You can document your manufacturing operations in FAT FINGER‘s no-code process documentation software. Use FAT FINGER’s drag-and-drop checklist builder to add the process steps. Add the complexity needed to your documented processes using FAT FINGER’s features such as Alerts, Conditional Logical, and Integrations. 

Once you’ve documented your operations, these processes are easily traceable from your FAT FINGER account, offering complete and security-controlled process transparency to measure operations against cGMP guidelines. 

For more information about FAT FINGER, and how to get started with this software, watch the below video: 

cGMP compliance step #2: Validate your manufacturing processes

Once you’ve documented your manufacturing processes, the next step is to validate these processes. Process validation refers to the analysis of data gathered throughout the design and manufacturing of a product, to confirm the process can reliably deliver products according to cGMP determined standards. 

This validation step is vital for determining what process controls are required. Does the equipment need to be calibrated? What process steps are vulnerable to error and deviation? Are your manufacturing processes consistently delivering the desired outcome?

The purpose of process validation is to ensure the varied inputs consistently deliver high-quality outputs. Note that this is an ongoing process, and the data and feedback gathered should be used for continuous process improvement.

cGMP compliance step #3: Use cGMP guidelines to document manufacturing SOPs

Document Standard Operating Procedures (SOPs) using the cGMP guidelines to build the required standards into your processes. Your aim is to ensure every employee completes each operational step consistently, in a controlled environment, and with quality standards guiding the intended use. 

Your SOPs should include departmental responsibilities, which is easy once you start assigning employees to the required process steps.

Once again, you can use FAT FINGER to document SOPs and assign staff to process tasks individually. 

For more information about Standard Operating Procedures and how to get started documenting SOPs, read: What are Standard Operating Procedures (SOPs)? How To Create SOPs in 10 Simple Steps

cGMP compliance step #4: Ensure proper maintenance of facilities and equipment 

For every industry operating under cGMP, buildings and facilities must be properly maintained to control manufacturing conditions and maintain safe and effective work. The same applies to the equipment used.

Compliant operations within work-premises are also reliant on your staff, i.e. your employees need to know what they’re doing. Make sure your employees have the appropriate skills, experience, and training to meet cGMP regulations. Use your SOPs to help your staff follow best practices and standards when carrying out their work. Make sure to assign ownership when authorizing selected individuals to make changes to records.

cGMP compliance step #5: Consistently review and update your procedures 

If you’re using outdated equipment, then it’s clear you won’t be cGMP compliant. You’ll want to revisit your manufacturing procedures regularly, to ensure you’re using the latest science and technology.

Set up annual review reminders, to run through your operations and identify outdated processes. This step is easy when you’ve documented your operations in FAT FINGER because of the process transparency this gives. 

Use cGMP guidelines to consistently deliver high-quality products

The purpose of cGMP is ultimately consumer protection. It’s to deliver quality products that are guaranteed to be effective, safe, and pure. Being cGMP compliant means your facilities are in good condition, your equipment is up-to-date, calibrated, and appropriately maintained, and your staff are fully trained and qualified.

A large chunk of cGMP compliance relies on documented processes – for transparency and guidance. Sign up for FAT FINGER to start documenting your manufacturing operations today, and consistently deliver cGMP compliant operations.