CGMP ISO 22716
WHAT IS CGMP?
CGMP Certification confirms the product's identity, composition, quality, purity, and strength which they represent in the market. In the United States (US), Current Good Manufacturing (cGMP) Practices Regulated by the Food and Drug Administration (FDA) concerning the designing, monitoring, measuring, controlling, Processing, and maintenance of manufacturing processes, Operational environment, and infrastructure facilities.
The word “current” was added to say that companies need to be up to date with the latest technology rather than running on what was a good practice in the past.
Pharmaceutical and biotechnology companies strictly follow CGMP processes to ensure their items are manufactured to specific requirements fulfilling the FDA regulations, which include identity, strength, quality, and purity with Compliance regulated by the Food and Drug Administration (FDA) US.
The FDA’s Role in cGMP Regulations:
According to the FDA, the importance of CGMP lies in the protection of consumer rights. The FDA designed CGMP regulations to “assure quality is built into the design and manufacturing process in every step.
Ensuring uniformity across all products is the main reason why the FDA regulates very strictly in drug manufacturing. A drug manufacturer will produce millions of pills, where only a fraction of a percent manufactured will be tested.
So, it is very important to ensure that all the pills are manufactured under the same conditions and also according to the same guidelines and standards. So, consumers can be confident that the pills sold are identical to those tested.
Products covered under CGMP Certification
- Manufacturing and testing of active pharmaceutical ingredients,
- Diagnostics,
- Foods,
- Pharmaceutical products and medical devices.
Who Needs GMP?
Pharmaceuticals, Bulk drug API manufacturers, Formulators, and Food Processors can certify for GMP certification.
Benefits of GMP Certification
- Enhances the food safety management system
- Increases consumer confidence in your products
- Helps to decrease operating costs due to rework and penalties due to non-compliance
- Helps boost export opportunities.
- Reduced duplication of inspections
- Cost-saving
The Certification Process
Online gap analysis allows us to see the current
- quality benchmark within your organization,
- the finances required
- the time required for this project (System and Certification Fee)
Your Estimate will be shared with you in 24 hours.
Upon Estimate Approval the project starts:
- A client executive is assigned to your project
- Contact information is shared with you
- The Payment details are provided to you
All Support is delivered Online.
The Client Executive will provide the Documentation Templates and explain to you how to amend it.
You will be required to perform the following tasks:
- Identify your core or business processes.
- Amend documentation that meets your business needs. (Policy statements, objectives, manuals, work instructions, job descriptions, forms.)
- Encourage employees to be aware of the new documented system
- Review, approve, and distribute the documents to those who need access to the information.
- Ensure procedures are being performed as documented.
- Ensure employees are trained properly for the tasks they are performing.
- Create effective reporting systems.
- Monitor the effectiveness of your processes through the use of measurable data, where possible.
- Review and take action to improve in the areas required.
- Plan internal auditing activities.
- Submit your management system documentation for review to ensure it complies with the applicable standard.
- Prepare for review by an external auditor to confirm that the system’s requirements are being satisfied and that the management system is implemented effectively.
- Obtain ISO Certifcaiton
- This periodic on-site review is usually conducted annually.
- It ensures that the certified business continues to comply with Standard requirements, as confirmed during the Recertification Audit at the certification cycle's outset.
- Most are conducted remotely.
Refer to learn more about Types of Audits
