The Indian pharmaceutical business is growing at a geometric rate and is the third biggest in the world by volume. So, most companies choose a very efficient method called third party manufacturing. In this arrangement, approved manufacturing facilities are in charge of making medicines and health products. In basic words, a brand owner solely concentrates on selling and marketing. The professional third-party manufacturers manage the intricate manufacturing process.
So, this outsourcing cuts costs by a lot and gets rid of the need for a lot of money to buy new equipment and plants. And it speeds up the time it takes to get new products to market. This cooperative effort lets both small start-ups and big companies quickly add new products to their lines without lowering quality standards.
The Crucial Role of WHO-GMP and ISO in Third Party Manufacturing in Pharma
Following the rules is the most important part of the pharmaceutical industry. So, for third-party manufacturing in the pharmaceutical industry to work, the third party manufacturers must have important worldwide and local certifications.
WHO-GMP Certification: The Standard for Quality around the World
WHO-GMP (World Health Organization – Good Manufacturing Practices) is not a choice; it is required for all medication makers. This certification ensures that items are always produced. It includes everything from designing the facility and keeping it clean to training employees and handling raw materials. Second, making sure that third party manufacturers follow WHO-GMP rules ensures that every batch is safe, effective, and pure.
ISO Certification: Improving Performance across the Board
ISO certifications, especially ISO 9001:2015, put a lot of weight on having a strong Quality Management System (QMS). The ISO system helps GMP by putting all of the business processes into writing. ISO certification also ensures that there is a focus on always becoming better and making customers happy. Both of which are important for long-term success in third-party manufacturing.
India’s strict GMP standards for Schedule M Compliance
In India, Schedule M of the Drugs and Cosmetics Act, 1940, defines the particular standards of industrial buildings, maintenance, and sanitary procedures. Naturally, all third-party producers must observe local legislation scrupulously. Since Schedule M corresponds to worldwide GMP rules, compliance guarantees that your products adhere to the finest local standards.
Stability Data Generation: Demonstrating Shelf-Life
The producer must create and maintain accurate stability data for each product composition. Hence, regulatory bodies like CDSCO demand such data to approve the product for market sale.
Audits and Inspections: Sustaining Ongoing Vigilance
Regular internal and external audits are a way of life as far as compliance is concerned. In fact, state and central drug authorities’ unannounced inspections keep third party manufacturers on their guard at all times of the day, going by the latest guidelines and protocols.
How Quality Control (QC) and QA Ensure Product Excellence in Pharma Third Party Manufacturing?
A compliant plant is the start, but a bold Quality Assurance (QA) and Quality Control (QC) system offers excellence to the manufacturing process. QA and QC are complementary but distinct functions that safeguard the product.
QA is a preventive system with the purpose of not making errors, but QC is a correcting process to locate them. In either case, they work in concert to provide a quality medicine product.
- Raw Material Testing: QC starts the moment components arrive. Accordingly, every batch of raw material and excipients is screened thoroughly for identity, purity, and strength before use.
- In-Process Checks: QA teams impose mandatory checks at each stage, from mixing and granulation to compression and filling. Thus, rigorous checking prevents deviations in the early stages.
- Finished Product Release: And only when the last, extensive testing by the QC lab confirms that the product meets all the specifications (e.g., dissolution, assay, uniformity) can the QA head release the batch.
- Validation: Critical equipment, processes, and cleaning procedures all have to be validated. And thus, validation is documentary proof that all systems perform as anticipated, yet another solid pillar of pharma pharma third party manufacturing.
- Documentation and Traceability: A Good QA system ensures proper documentation of every step, ingredient, and individual involved. Thus, this complete traceability facilitates quick investigation and recall in case any issue arises.
Legal Agreements and Due Diligence for Seamless Third Party Manufacturing
The primary regulator in India for pharma and medical device companies is the Central Drugs Standard Control Organisation (CDSCO). Thus, all formalities and procedures of pharma third party manufacturing are directly based on CDSCO guidelines.
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Step-by-Step Process of Third Party Manufacturing Pharma Products in India
First of all, the brand owner has to procure the required product licenses from the State Drug Authority, declaring third party manufacturers as the place of manufacture. Lastly, following the Drugs and Cosmetics Act of 1940 and the standards that came after it. A safe option for businesses to do business is to work with a company like Daffohils Laboratories that specializes in following tight rules.
Conclusion
Regulations are the last line of defense for the quality of the pharmaceutical industry. You need to follow the rules given by the WHO-GMP, ISO, and CDSCO if you want to perform third party manufacturing well. A system like this, based on good QA and QC, makes the market more valuable and less risky. You can be sure that your firm will always deliver safe and high-quality products. If you partner with a manufacturer like Daffohils Laboratories that follows the standards and is honest about what they do. This lets you concentrate on growing your business and being the market leader in this competitive market.
Frequently Asked Questions
Does a brand owner need to get a specific drug license in order to do third-party medicine production?
Yes, the brand owner has to get a Drug License for the third-party manufacturing.
What is the recommended frequency for the brand owner to conduct a quality check or audit of the manufacturing facility?
Even though no law says they have to, big companies do supplier audits at least once a year to make sure they are following the rules.
What does the term CDSCO mean, and what is its primary function in drug regulation?
The Central Drugs Standard Control Organization (CDSCO) is India’s national drug regulator.