What Are the Certifications and Standards Required for Pharmaceutical Medicine Export
What Are the Certifications and Standards Required for Pharmaceutical Medicine Export: Looking at the increasing scope of the pharma industry multifarious pharma companies want to introduce themselves as a pharma exporter. Exporting pharmaceutical medicines involves adhering to various certifications and quality standards to ensure product safety, quality, purity, and compliance with international regulations.
The specific requirements may vary depending on the destination country, so it’s crucial to research the regulations of the target market where you want to export your pharma products. However, some common certifications and standards that are typically required for pharmaceutical medicine exports include, in this blog we mentioned What Are the Certifications and Standards Required for Pharmaceutical Medicine Export.
ISO ( International Organization for Standardization)
ISO aims to ensure that your exported pharma products and services are safe, dependable, secure, and of superior quality. ISO represents strands, training modules, research papers, guidelines, research papers, and certification. Getting ISO Certification for your product house could add value and raise your brand image globally.
It will help in finding new market opportunities easily and expand the market fast. Having an Internationally Accredited Certification for the export house will help gain acceptance quickly and maintain a reputed image at the international level.
- Reducing Cost
- Providing high-quality products
- Introducing new healthcare formulations in the market
- Boost your sales
Good Manufacturing Practices (GMP)
GMP is an essential certification that is a part of the 100% quality assurance of medicinal products that ensures pharmaceutical products are manufactured, tested, and stored according to appropriate international quality standards. Many countries and regions have their own GMP requirements, such as the U.S. FDA’s cGMP (current Good Manufacturing Practices) or the EU GMP.
- Provide Protection for the international market
- Increase consumer satisfaction
- Control of the manufacturing process and practices
- Quality Control
Pharmaceutical Product Registration(PPR)
For the best export business Pharma product Registration is one of the Certifications and Standards Required for Pharmaceutical Medicine. Most countries require the pharmaceutical product to be registered with their local regulatory authority before it can be imported and sold. This involves providing extensive documentation, including product dossiers, stability data, and quality control records.
- Promotion of Indian products and services
- Quality Assurance
- Organizes trade fairs
- Raise the profile of pharma companies in the global market
Certificate of Pharmaceutical Product (CPP)
The World Health Organization (WHO) issues CPP certificates that are listed in the important Certifications and Standards Required for Pharmaceutical Medicine Export, which provide information about the pharmaceutical product’s marketing status and manufacturing authorization. It is often required for international trade. Moreover, it is considered a “gold standard” certification for security management professionals and demonstrates your knowledge and competency.
- Ensure product’s quality, safety, and efficacy
- The product is manufactured under good manufacturing practice
- Follows the correct guidelines
- Prove information about the drug
Good Distribution Practices (GDP)
GDP refers to Good Distribution Practices that describe the minimum standard that a wholesale distributor must meet the the quality and integrity of the medication that they export. GDP ensures the proper handling, storage, and distribution of pharmaceutical products, including cold chain management for temperature-sensitive products. Compliance with GDP is essential for the transportation and distribution of medicines.
- Higher sales volume
- Empowering pharma companies through training
- Enhancing product quality
- Patient protection
Labeling and Packaging Requirements
Packaging is the basic need of pharmaceutical products when you export your medication your packaging is required to match international quality standards. Make sure that your pharmaceutical products are labeled and packaged in compliance with the specific requirements of the target market, including language, format, and content. Apart from this, pharma regulations in India include a veg or nonveg symbol, nutritional information, net quantity, lot number of batch identification, etc.
- Directly impacts on sales or profit
- Display brand logo
- Attractive packaging attracts customers
- Provide information regarding pharma products
Pharmacopeial Standards
A pharmacopeial standard is an official collection of quality standards and specifications for medicines and their ingredients such as the United States Pharmacopeia (USP) or the European Pharmacopoeia (Ph. Eur.), which define international quality standards for pharmaceutical ingredients and finished products. Compliance with relevant pharmacopeial standards is typically needed.
- Safe, effective, and appropriate quality
- Develop quality standard
- Promoting Innovation
- Help to ensure that new medicine is safe
Algen Healthcare ISO, WHO, GMP, and GLP Certified Pharmaceutical Exporter in India
Algen Healthcare was launched in the year 2000. When it comes to Indian drug makers and distributors, Algen Healthcare is undeniably top-positioned as it is the country’s largest company by market capitalization and has experience with generic pharmaceuticals. It is certified by ISO, GMP, WHO, GLP and got 200+ approvals from reputed organizations. It exports 1500+ superior quality DCGI and FSSAI-approved pharmaceutical products such as Antibiotics, Anti-infective, Pediatric, Health Supplements, Cardiology, Diabetology, Gynecology, Dry Injectables, Softgel and Anti-Hiv. To match international quality standards pharma companies in India strictly go along with the guidelines and instructions of WHO and GMP.
