GMP Skill Booster
Quality Management Fundamentals
The basic concepts of Quality Assurance (QA), GMP and Quality Control (QC) are interrelated. The sum total of all these entities together comprises the pharmaceutical quality system (PQS). The functions or roles of QA, GMP, and QC are collectively critical to the effective and safe production and control of medicinal products.
On completion of this skill booster, you will be able to:
- Recognize how attention to manufacturing a quality product reflects on day-to-day operations
- Identify the role of Quality Assurance in pharmaceutical manufacturing
- Recognize how companies use GMP rules to minimize errors in manufacturing
- Identify the main roles and responsibilities of Quality Control
- Recognize the key elements of a pharmaceutical quality system
Good Documentation Practice
Manufacturing instructions should clearly and accurately define each manufacturing process step. Production operators should rely upon following these approved steps of manufacture, not draft instructions. GMP rules do not allow companies to use draft, trial or out-of-date documents in commercial manufacture. The instructions, however, should be based on experience with completing the tasks. If problems arise, the procedures should be revised to reflect exactly what is required.
On completion of this skill booster, you will be able to:
- Recognize the importance of procedures
- Recognize the importance of record keeping
- Identify the possible consequences of not completing and certifying GMP documents
- Identify how to complete batch records and associated supporting documents
Cleaning Practices in GMP
Cleaning and sanitation programs are an important part of GMP, as they protect products from environmental contamination and cross-contamination with other materials and products. These programs are also designed to protect us from the effects of hazardous materials.
On completion of this skill booster, you will be able to:
- Define the meaning of the words "cleaning" and "sanitation"
- Recognize why you need to clean before you sanitize
- Identify the GMP requirements for documenting cleaning and sanitizing activities
- Explain the reasons why you must use only approved cleaning and sanitizing materials
- Explain why cleaning and sanitation prevents product contamination
Preventing Contamination in GMP
Prevention of contamination measures are taken extremely seriously by the GMP facilities as it can adversely affect the quality and safety of food and drugs they produce.
To control contamination, GMP facilities have to implement strict hygiene and sanitation procedures, robust cleaning programs, use dedicated equipment & facilities, carefully design production lines and material storages, perform regular quality control tests and QA release activities throughout the supply chain.
On completion of this skill booster, you will be able to:
- List the common types of physical and chemical contaminants
- Describe the consequences of producing contaminated products
- Identify the potential sources of contamination at your worksite
- List some ways that you can prevent contamination
- Potential sources of physical and chemical contamination
- How your facility has been designed to control contamination?
- Some practical ways to prevent contamination
Role of Warehouse in GMP
The quality of a pharmaceutical product is defined as one that is pure, correctly identified, effective and safe to use. Customers and patients have an ethical (and legal) right to expect quality pharmaceutical products.
The warehouse plays a pivotal role in manufacturing quality products, as it is responsible for all incoming goods (including labeling and packaging) and for releasing finished products. Therefore, there are GMP rules in place to ensure that materials are handled and stored properly, while appropriate documentation is maintained.
On completion of this skill booster, you will be able to:
- Explain the role of the warehouse
- List the GMP procedures needed in the warehouse to control incoming goods
- Identify the GMP requirements for handling starting materials and finished products in the warehouse
- Recognize the GMP issues surrounding release of finished products to the marketplace
- Recognize issues around transport of goods to and from the public
- Recognize how returns ore handled by the company
- Identify the different documentation needed in the warehouse
Good Laboratory Practice
Testing laboratories provide a vital function with regard to provision of accurate and reliable test results. Their customers rely upon these results to make important decisions particularly in the areas of patient health, consumer protection and the safety or suitability of materials, samples and products.
On completion of this skill booster, you will be able to:
- Recognize what comprises a laboratory quality manual.
- Relate the safety requirements of the QC laboratory to day-to-day work practices
- Distinguish between the different types of laboratory documents
- Stale the rules for record keeping and data recording
- Recognize the key features of test methods and specifications
Overview of Microbiology Tests
Micro-organisms are a group of organisms that include bacteria, moulds, yeasts, and viruses. They are also very adaptable and can live and multiply in conditions other living things cannot survive in. Micro-organisms are also naturally all around us in the environmental air, on our skin, within row materials and water, on packaging, and on production equipment.
Microbiology is the scientific study of microscopic organisms, often called “micro-organisms” or “microbes”. Although microorganisms are small, the mass of microbial life on earth is 25 times greater than the total mass of animals. The external surfaces of all animals and plants are covered with micro-organisms, not to mention animals’ internal surfaces. The human body contains about 100 trillion microorganisms.
On completion of this skill booster, you will be able to:
- Describe what types of micro-organisms may be found in pharmaceutical products, water, and the environment
- Identify the major sources of microbial contamination and what is considered to be “objectionable”
- Identify microbial contamination problems in the workplace
- Identify procedures to reduce the chance of microbial contamination
Overview of Packaging Operations
Customers of pharmaceutical products expect products that are safe and effective. One of the ways to ensure that products are safe and effective is by producing finished products that ore correctly identified. Product and labeling mix-ups can result in potentially serious consequences.
As such, GMP rules require that products rule be correctly identified with the correct name, ingredients, strength, and botch information. There must be no unspecified components present.
On completion of this skill booster, you will be able to:
- Define what is meant by mislabelling
- State the critical GMP requirements for packaging controls
- Describe the GMP controls for pre-printed matter
- Identify the GMP requirements of selling up a packaging line
- State the importance of online controls
- Perform basic reconciliation calculations