Every industry has its own set of challenges.
For some, ensuring a smooth supply chain is the topmost priority, while for others, the rate of manufacturing could be the most crucial aspect.
When it comes to the pharmaceutical industry, ensuring quality is at the top of that priority list. Maintaining good quality is not possible without a robust plan in place, a set of guidelines to adhere to and a foolproof audit plan.
That is where GMP comes in.
What is GMP?
GMP or Good manufacturing practice is a system that ensures that your products are being manufactured and tested in line with the required quality standards in line with industry best practices.
It is typically ensured through the effective use of a quality management system (QMS) and enables you to implement proper quality control and minimize risks.
How GMP Works?
GMP provides guidance for manufacturing, testing, and quality assurance in order to ensure that a manufactured product is safe for human consumption or use.
It covers every aspect of production, starting from sourcing raw materials, to their storage, to manufacturing processes and even training your employees and their personal hygiene requirements.
Following the principles allows you to set up robust SOPs and workflow, identify gaps in processes and sources of deviation from desired quality and maintain suitable environments for storage and testing of products.
GMP encompasses Quality Systems, Facilities and Equipment Systems, Materials Systems, Production Systems, Laboratory Control Systems and Packaging and Labeling Systems.
Basic Principles of GMP.
Good Manufacturing Practice involves the following basic principles :
- Manufacturing facilities must maintain a clean and hygienic manufacturing area.
- Manufacturing facilities must maintain controlled environmental conditions in order to prevent cross-contamination from adulterants and allergens that may render the product unsafe for human consumption or use.
- Manufacturing processes must be clearly defined and controlled. All critical processes are validated to ensure consistency and compliance with specifications.
- Manufacturing processes must be controlled, and any changes to the process must be evaluated. Changes that affect the quality of the drug are validated as necessary.
- Instructions and procedures must be written in clear and unambiguous language using good documentation practices.
- Operators must be trained to carry out and document procedures.
- Records must be made, manually or electronically, during manufacture that demonstrate that all the steps required by the defined procedures and instructions were in fact taken and that the quantity and quality of the food or drug was as expected. Deviations must be investigated and documented.
- Records of manufacture (including distribution) that enable the complete history of a batch to be traced must be retained in a comprehensible and accessible form.
- Any distribution of products must minimize any risk to their quality.
- A system must be in place for recalling any batch from sale or supply.
- Complaints about marketed products must be examined, the causes of quality defects must be investigated, and appropriate measures must be taken with respect to the defective products and to prevent recurrence.
Why is GMP so important to the Pharmaceutical Industry?
The pharmaceutical industry has a responsibility to ensure a safe and sufficient supply of medicinal products.
Adhering to Good Manufacturing Practices ensures that the drugs produced by a company are of highest possible quality. If the pharmaceutical industry does not follow GMP guidelines, it runs a huge risk of producing inferior quality products, which may cause severe harm to the consumers.
Not just that: if one of the batches produced does not meet the regulatory quality standards, it usually means that the fault lies in the process used to manufacture them, implying that batches of other products might be of inferior quality as well and hence, not fit to consume.
This scenario is also dangerous because it means that patients who need a certain medication are unable to receive them in time, which may further lead to health complications.
Imagine the impact it would have on the reputation of the company!
In case of a poor-quality batch, the company also needs to recall the products and resend a fresh batch that meets the desired quality standards. As you already know, product recalls cause a huge waste of time, money and resources.
GMP has proven to boost export opportunities in the pharmaceutical industry. So embracing its principles not only allows you to mitigate risks, save costs and build a reputation but also grow your business.
How can we help with GMP?
With years of experience in the pharmaceutical industry and having helped dozens of reputed clients from across the globe, we have a range of seamless, smart and 21 CFR Part 11 and GMP compliant solutions that help you establish prescribed best practices. We help you set up a robust Quality Management System from scratch and empower you to ensure a high level of quality in manufacturing.
Here’s an overview of our GMP compliant solutions:
WMS drives warehouse operations with maximum efficiency and helps you adhere to FEFO. It also lets you automate dispatch and loading, eliminate wrong shipments and manage returns, damaged and expired goods as per GMP.
PHARMISION WOMS takes a unique data-driven approach to capture raw material and inventory data at every event, ensures sequence control in workflow and keeps stakeholders informed of operating efficiency of the entire warehouse in real-time.
Manufacturing Operations & Traceability System ensures error-free and guided execution of the entire production process and improves quality of products and processes.
eLogs digitize your area and equipment logs, enabling you to verify or review them online. It also lets you configure and create log forms to suit your SOPs.
If you are interested in implementing GMP and want to know more about it, please feel free to get in touch with us at https://www.pharmision.barcodeindia.com/