The pharmaceutical industry is one of the most heavily regulated industries due to the implications product quality has on public health. Automation and optimization of key processes such as manufacturing, supply chain, etc., help companies enhance their productivity while maintaining high-quality standards. Life science ERP solutions are now embedded with added functionalities to take care of quality control and regulatory requirements.
For example, software tools are now available to ensure SOX compliance in the pharmaceutical industry. Along with maintaining regulatory requirements, life science ERP solutions also enable focusing on vital aspects of a pharmaceutical supply chain. The backbone of the pharmaceutical supply chain is traceability. To understand why traceability is important in pharma, check out our article at the previous link.
Amongst the various regulations that the pharmaceutical industry is under, GMP guidelines optimize and evaluate the manufacturing process. Let’s look at these guidelines in further detail.
What Is GMP?
Good Manufacturing Practices (GMP) is that part of quality assurance that ensures that the products are consistently manufactured and controlled to the quality standards appropriate to their intended use. They are a set of principles and procedures that, when followed by manufacturers for therapeutic goods, help maintain the required quality of the products.
The most important tenet of GMP is that quality cannot be tested into a batch of products but must be built into each batch of products during all the stages of the manufacturing process. The guidelines are designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.
Some of the main risks that GMP helps companies mitigate are,
- Unexpected contaminations of products, cause damage to health or even death.
- Incorrect labels on containers could sometimes lead to harmful formulations or delivery of the wrong medicines to the patients.
- Insufficient or too high of a number of active ingredients, resulting in ineffective treatment or adverse effects.
Principles Of GMP
GMP, as stated above, is a set of guidelines including basic control measures and procedures to be followed, to meet the standard specifications of products that are safe for human use. These regulations address different areas including cleanliness, personnel qualifications, and record keeping. Following are 10 basic principles which need to be addressed to follow good manufacturing practices.
Principle 1: Step By Step Written Procedures
All operating procedures and work instructions should be written down as standard operating procedures, and made available to all the employees to better understand the facility's workflows. The written procedures should be concise and logical so that they are easy to understand and follow.
Principle 2: Follow Procedures
It is critical that all the SOPs and written procedures are appropriately followed without any deviations to ensure a controlled and consistent performance.
Principle 3: Document Work
Prompt and accurate documentation serves as a record that helps maintain compliance and traceability. In case of an error, these records serve as the basis of investigation.
Principle 4: Validate Work
Establishing documentary evidence of the products, processes, and procedures enables their validation at each stage of manufacturing.
Principle 5: Integrate Productivity, Quality, And Safety Into Facilities And Equipment
The company facility should be constructed and designed in a way so as to reinforce the goals of quality, consistency, and minimization of errors at all stages of production.
Principle 6: Maintain Facilities And Equipment
Proper maintenance of equipment and the facility with valid documentation minimizes any safety concerns and helps avoid potential issues relating to contamination and quality control.
Principle 7: Define, Develop, And Demonstrate Job Competency
Capacity building of the employees through training on theory and practice of GMP as well as role-related training must be carried out. Appropriate training enables employees to demonstrate job competence by producing quality products in a safe and efficient manner.
Principle 8: Make Cleanliness a Daily Habit
Incorporating cleanliness, good hygiene, and a strict regime for sanitization ensures the protection of the product from contamination.
Principle 9: Build Quality Into The Product
Every step of the product life cycle should have effective controls such as control components, controlling the manufacturing process, packaging and labeling controls, and holding and distribution controls. These controls at different levels of manufacturing affect the final quality of the product.
Principle 10: Conduct Compliance And Performance Audits
The only way to evaluate how well GMP is being implemented is to conduct planned and periodic audits. Audits can be conducted internally to ensure GMP compliance, or externally by bodies such as the FDA, etc.
GMP compliance is no longer an option but a mandate for every pharmaceutical company. By following GMP guidelines quality should be built into the product. They cover all aspects of the manufacturing process prior to supply. Compliance with GMP minimizes the risks associated with pharmaceutical manufacturing that could potentially harm consumers. Overlooking GMP guidelines can result in manufacturing an unsafe product leading to costly lawsuits, lost licensure, damaged reputations, and even loss of life.