GMP regulations are set by regulatory bodies like the FDA to ensure product safety for medicinal products. A well-implemented quality assurance (QA) system can help you comply with these rules.

QA involves checking and monitoring systems, procedures, and equipment. It also addresses issues and complaints, saving a company from expensive product recalls.

Process Validation

Process validation is a framework for establishing documentation that an established process can consistently produce a quality product. It’s essential for any new product and must be performed on any existing processes that have been changed, expanded (volume or scope), or experienced a downward trend in performance.

For example, your company manufactures medicine to treat fevers and dysentery. The same equipment is used to make both medicines. If manufacturing one batch contaminates the other, it could mean that patients receiving fever medicine would be exposed to toxins produced by the tablets made for dysentery. GMPs require that a formal process be in place to prevent cross-contamination. This is why a well-developed process validation plan should be in place.

Typically, a VMP is drafted by a team that includes members from quality assurance, engineering, and manufacturing. A cross-functional approach is essential because each member can provide valuable insights from their unique perspective.

It’s also a good idea to involve outside experts. For example, professional technical writers can help ensure procedures are clear and logical and include the correct information. They may also perform usability tests to determine how easy it is for people to follow the documents and understand what they’re meant to do. This is a valuable step in reducing errors and improving efficiency.

Good Manufacturing Practices

During the manufacturing phase, GMP regulations help to ensure product safety. This is done by preventing contamination, improper handling or processing, and ensuring the product meets specifications. GMP rules can be violated during the manufacture of drugs and biologics by poor hygiene, temperature control, cross-contamination, or failure to follow specific manufacturing instructions. These issues can have negative consequences on the health and safety of consumers, as they could make patients more ill or even cause fatal complications.

A quality team can help a pharmaceutical company stay GMP manufacturing projects compliant. The team will focus on improving current procedures, conducting quality assessments of operations, and implementing corrective measures. It will also perform scheduled monitoring of instruments, equipment, and processes to assess their condition. Maintaining accurate records of all batch deviations is crucial so QA can investigate and resolve them.

The people involved in the manufacturing process are another vital aspect of cGMP compliance. Having well-trained staff who understand the importance of adherence to good manufacturing practices can decrease the likelihood of mistakes that may result in non-compliance with FDA requirements. It is also a best practice to provide employees with compliance training regularly to keep up-to-date with the latest changes to procedures and standards. This will allow them to better prepare for FDA inspections or self-inspection visits.

Training

Training is a vital part of any GMP compliance program. FDA regulations require that all personnel involved in the manufacturing of a product receive regular training to ensure they are aware of GMP requirements and how they apply to their specific roles. Training also helps employees understand why certain rules are in place so they can better recognize when a deviation may lead to problems with patient safety or the quality of the finished product.

Training should be specific to an employee’s role and conducted by qualified trainers with relevant experience. This helps keep the material engaging and ensures all required information is covered. It is also essential to provide ongoing training for new hires or those whose jobs change to ensure they are familiar with all applicable GMP rules and how they apply to their roles.

Finally, training should be updated regularly to account for any changes in processes or equipment, revalidate existing procedures, and cover new CAPAs identified during an inspection. This ensures all personnel know the latest changes to a company’s production and quality assurance processes.

Adding training to your compliance program can improve worker morale and help maintain a high level of quality in the facility. It can also help reduce product recalls, reduce negative customer feedback, and protect a brand’s reputation.

Inspections and Audits

GMP requires that all development, manufacturing, and testing procedures be documented. It also requires that these procedures be followed consistently to achieve a quality outcome. Written procedures must be presented to all employees, and any deviations from the standard must be assessed before a batch is released.

In addition to training, QA representatives must regularly conduct self-inspections or internal audits. This enables QA to assess whether the rules established by management are being adhered to by personnel and that corrective action is being taken when an error is discovered.

Surveillance is a less formal process, but it is equally essential to apply good manufacturing practices. Surveillance focuses on the ongoing performance of a process rather than specific audit and inspection activities.

As a result, it may not detect all non-compliant practices, but it will provide valuable insights into the effectiveness of a company’s internal control systems.

While a company must be able to produce a quality product that can pass laboratory tests, the behavior, attitude, and care of personnel will ultimately determine the safety of drugs given to patients. This is why it is essential that all personnel understand GMP rules and why they need to follow them. This knowledge can help them recognize when a manufacturing deviation could affect patient health and allow them to take immediate corrective actions.