GMP in Pharmaceutical Industries
Provide safe pharmaceutical products to your customers by applying for cGMP Certification in Sri Lanka.
COVID-19 pandemic has a considerable impact on patients, citizens, and businesses in the long run. It may force marketing bodies to operate under business continuity mode, impacting the standard way of working continuity of supplies of medicines which is a priority for public health. The ultimate aim of the EU legislation on medicinal products is to ensure high-level standards of quality, safety, and efficacy of medicines priority for public and animal health.
In this context due to this crisis all over the world, the European Economic Area (EEA), GMP Certification time-limited are automatically extended until the end of 2021. The European Medicines Agency (EMA) is waiving its fees for on-site inspections of manufacturing sites and blood establishments, especially during the pandemic.
When consumers buy drugs at the pharmacy they trust that the products are safe, high quality, and serve their advertised purpose as stated. The drug manufacturer has a big role in understanding Good Manufacturing Practices GMP in the pharmaceutical industry that conforms to the guidelines controlling the authorization and licensing of the manufacturing and sale of pharmaceutical products. The FDA currently offers 34 distinct final guidance documents which include requirements for process validation, data integrity, quality metrics, and countless other topics to assure that their products are consistently high in quality, from batch to batch.
GMP is also known as cGMP. Here “c” stands for current. If you’re wondering why “current” Good Manufacturing Practices is to be used. In this blog, we’ll cover the official definition for these essential guidelines in terms you can understand with insights from the pharma industry. Current good manufacturing practices to assure proper design, monitoring, and control over manufacturing processes and facilities uses currently updated techniques and technology.
What is cGMP?
In cGMP, organizations can avoid many of the quality failures which threaten patient safety and provide them with quality and effective drugs. Being compliant with cGMP regulations drastically reduces the number of batch recalls and decreases the number of adverse reactions caused due to drug contamination, deviations, or mix-ups. cGMP sets guidelines the way that manufacturers guarantee safety, efficacy, and consistency from batch to batch of the products in the industry.
cGMP systems include a series of controls Management Systems for
- Quality Raw Materials
- Operating Procedures
- Detecting Deviations
- Investigating Deviations
- Reliable Testing
Therefore, practices required by the cGMP must assure that quality is built into the design and manufacturing process at every step and process that is reliable and reproducible.
Guidelines to be followed for the compliance of the GMP under Title 21 CFR
- To maintain clean and hygienic manufacturing facilities
- To maintain controlled environmental conditions to prevent cross-contamination
- To ensure consistency and compliance with required specifications for manufacturing processes
- Following Good Documentation practices
- Regular training of operators to the employees
- Records of manufacture and distribution history of a batch can be traced and retained and retrievable
- System of Recall must be in place to solve the query
- Complaints about marketed products must be examined
- Appropriate measures must be taken concerning the defective products and to prevent their recurrence
- Pillars of GMP
For pharmaceutical and other related industries, the ‘5Ps of GMP’ is a useful way to ensure that the quality, consistency, and safety of your end products. By focusing on the 5Ps manufacturers can be confident they are compliant and able to demonstrate their compliance to cGMP Directives.
Everyone involved in manufacturing and processing the chain of a drug must have clear roles and responsibilities. Employees must know how to follow procedure and their performances must be trained to follow procedure. Training methods must be periodically reviewed.
- Procedures and Process
As stated above, GMPs ensure that public trust in the manufacturing quality to achieve and how they need to meet the required standards in their operations. A process is a series of related tasks undertaking a prescribed way undertaking a process or part of a process to achieve a consistent result. All procedures must be laid out clearly with routinely recording data at key stages of manufacture so that finding the source of any issue or non-conformance in quality will be much easier.
Premises relate to questions that how can you tell your equipment has been properly calibrated? What kind of facility setup do you have to manufacture appropriate drugs? How will you prevent contamination and recalls? The design of a facility must be continuously validated to take these requirements into account.
All of these ‘Ps’ are intended to support the end-to-end responsibility, ensuring goods that come into and leave the facility are in good order and handled appropriately. Overall, components of following GMPs the results of testing should be recorded for internal or external audits of their products and research, development, manufacture and packaging, testing, sampling, status control, stability testing, and record-keeping.
EMA role in GMP
Good manufacturing practice (GMP) describes the standard guidelines that must meet in their production processes and planning. The European Medicines Agency (EMA) coordinates inspections of manufacturing sites for medicines whose marketing authorization in the EU is submitted.
EMA Agency plays a key element in coordinating and harmonizing GMP activities involved in
- Coordinating the preparation of new and revised guidance on GMP
- Ensuring common interpretation of EU GMP requirements
- Developing EU-wide procedures on GMP inspections
- Facilitating cooperation between the Member States for inspections
Inspection for Pharmaceutical products used in COVID-19 Pandemic
Plasma master file (PMF) inspections
EMA is responsible for coordinating inspections for products derived from blood or blood plasma, in which collection, testing, processing, storage, and distribution are carried out.
- Vaccine antigen master file (VAMF) inspections
EMA is responsible for coordinating inspections of vaccine antigen manufacturing sites under the VAMF certification procedure.
It is important to note that the GMP guidance list necessarily needs to be conducted to reach quality and safe outcomes. For instance, the company can itself decide the procedure of how to comply with the GMP guidelines depending on their own needs and available resources.