The pharmaceutical industry is a highly regulated industry. To meet the regulatory requirements, a lot of good manufacturing practices guidelines are required to be followed. This article is an introduction to the key requirements of the GMP guidelines for a pharmaceutical company to produce better and quality products.
The most important part of GMP is quality. Pharmaceutical products must be free from contamination and must comply with the predetermined specification. Products that do not meet the specification may be ineffective and unsafe for the consumer.
Manufacturing facilities are required to follow specific procedures for manufacturing of pharmaceutical products. These procedures are about raw materials, equipment, and record maintenance for all activities.
Safety is another important part of GMP. Products manufactured in facility must be safe for the consumers. The product must be tested for potential hazards before the product is released for distribution. If product is unsafe then the manufacturer must take steps to resolve the issue.
The product must be effective and safe for the patients and product should comply the predetermined specification. Product safety and effectiveness must be ensured by the manufacturer before the distribution of the products.
2. Quality of Raw Material used in Manufacturing: Raw materials are the key ingredients of the pharmaceutical products and these must be tested for quality before these are used in production.
3. Validation of Process and Equipment: All manufacturing processes and equipment must be validated to ensure consistent results in all batches.
4. Documentation and Record Maintenance: Accurate results of all manufacturing and testing activities should be maintained including raw material and equipment processing.
5. Quality Control of Finished Products: Finished products must meet the required quality and standards. Finished products must be tested by quality control laboratory before release for distribution
6. Packing and Labeling: Packing and labeling of the products must be accurate and must have all necessary information printed on them.
7. Qualified and Trained Employees: The employees working in the manufacturing and analysis of the raw material and final products must be qualified and trained for the work they do.
8. Storage and Distribution: Pharmaceutical products produced in a GMP facility must be stored and distributed in a way that ensures the product safety and quality.
9. Product Recall: If any issues are found in product quality, then manufacturers must have procedures for product recall and investigation.
When a company follows the GMP norms, this shows the commitment of the company towards the patient health and safety. It ensures that good quality raw materials are used in manufacturing and products are free from contamination and dangerous ingredients.
Meeting the GMP standards is very expensive because company need to appoint qualified and efficient staff. Training of employees also cost the company but an effective and quality product improves the reputation of the company and it also promotes the brand.
Product failure may cause a serious impact on company reputation that can lead to financial loss to the company. Product recall is another problem for the company because the recalled product is mandatorily destroyed and cannot be reprocessed. It can damage the brand reputation and it will cost extra to relaunch the product in the market.
If improper documentation or data falsification is found in any company then it may lead to criminal charges. Any health issues or death of the patients after consuming the drug products can send the higher management of the company behind the bars, as recently observed with a company manufacturing cough syrups.
As we understand here. Adherence to GMP regulations is essential to produce quality and safe products for the patients consuming pharmaceutical products. A company must have ethics to produce safe and effective products because medicines are not food, but one takes them to cure himself, trusts them and thinks his health will get better.
What is GMP
GMP stands for good manufacturing practices, a well-recognized globally accepted standard to produce pharmaceutical products. GMP guidelines cover from facility design and execution of manufacturing process to quality control of the final products. GMP certification is required for all pharmaceutical manufacturing facilities to ensure that company is manufacturing safe and high quality products.What are the GMP Requirements for Pharmaceuticals
Good manufacturing practices (GMP) is a set of guidelines and these standards are mandatory to be followed by a pharmaceutical company to produce safe and quality products. The GMP is mainly based on the principles of safety and quality.
The most important part of GMP is quality. Pharmaceutical products must be free from contamination and must comply with the predetermined specification. Products that do not meet the specification may be ineffective and unsafe for the consumer. Manufacturing facilities are required to follow specific procedures for manufacturing of pharmaceutical products. These procedures are about raw materials, equipment, and record maintenance for all activities.
Safety is another important part of GMP. Products manufactured in facility must be safe for the consumers. The product must be tested for potential hazards before the product is released for distribution. If product is unsafe then the manufacturer must take steps to resolve the issue.
The product must be effective and safe for the patients and product should comply the predetermined specification. Product safety and effectiveness must be ensured by the manufacturer before the distribution of the products.
Key Principles of GMP
1. Design and Maintenance of the Manufacturing Facility: Manufacturing facility must be designed to prevent and control the contamination, mix-up of products and errors in process of manufacturing and handling.2. Quality of Raw Material used in Manufacturing: Raw materials are the key ingredients of the pharmaceutical products and these must be tested for quality before these are used in production.
3. Validation of Process and Equipment: All manufacturing processes and equipment must be validated to ensure consistent results in all batches.
4. Documentation and Record Maintenance: Accurate results of all manufacturing and testing activities should be maintained including raw material and equipment processing.
5. Quality Control of Finished Products: Finished products must meet the required quality and standards. Finished products must be tested by quality control laboratory before release for distribution
6. Packing and Labeling: Packing and labeling of the products must be accurate and must have all necessary information printed on them.
7. Qualified and Trained Employees: The employees working in the manufacturing and analysis of the raw material and final products must be qualified and trained for the work they do.
8. Storage and Distribution: Pharmaceutical products produced in a GMP facility must be stored and distributed in a way that ensures the product safety and quality.
9. Product Recall: If any issues are found in product quality, then manufacturers must have procedures for product recall and investigation.
Why GMP is Important?
As we have gone through the requirements of GMP in pharmaceuticals. Now we can say if a company doesn’t follow GMP regulations, it may cause product recalls, financial penalties, or criminal charges. Safety of the patients must be at top priority for the pharmaceutical manufacturers. Not following the GMP regulations means the company is comparing the patient safety.When a company follows the GMP norms, this shows the commitment of the company towards the patient health and safety. It ensures that good quality raw materials are used in manufacturing and products are free from contamination and dangerous ingredients.
Meeting the GMP standards is very expensive because company need to appoint qualified and efficient staff. Training of employees also cost the company but an effective and quality product improves the reputation of the company and it also promotes the brand.
Consequences of not Meeting GMP Requirements
Companies not meeting the GMP regulations may face a lot of consequences. One most important consequences are that product may not be safe for use and it can cause serious health problem to the patients. The company could be fined by the government or regulatory authorities.Product failure may cause a serious impact on company reputation that can lead to financial loss to the company. Product recall is another problem for the company because the recalled product is mandatorily destroyed and cannot be reprocessed. It can damage the brand reputation and it will cost extra to relaunch the product in the market.
If improper documentation or data falsification is found in any company then it may lead to criminal charges. Any health issues or death of the patients after consuming the drug products can send the higher management of the company behind the bars, as recently observed with a company manufacturing cough syrups.
As we understand here. Adherence to GMP regulations is essential to produce quality and safe products for the patients consuming pharmaceutical products. A company must have ethics to produce safe and effective products because medicines are not food, but one takes them to cure himself, trusts them and thinks his health will get better.
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