By Pulse Pharma Mfg Co.3 min read
In this article
- 1. A valid manufacturing licence for your dosage form
- 2. GMP practice and certificates
- 3. In-house quality control
- 4. Experience with your dosage form
- 5. Samples before you commit
- 6. Clear minimum order and lead time
- 7. A quote that shows what is included
- 8. Help with packing and artwork
- 9. Easy communication
- 10. Visit the plant
- What to do next
Choosing a third party pharma manufacturer is the most important decision a new pharma brand makes. Your product, your brand name and your customers' trust all depend on someone else's plant. Gujarat has many manufacturers, so use this checklist to compare them on facts, not on promises.
1. A valid manufacturing licence for your dosage form
Ask for a copy of the manufacturing licence. In Gujarat it is issued by the state drug authority. Check that it is current and that it covers the dosage form you want, such as tablets, oral liquids or injections. A manufacturer can only make what its licence allows.
2. GMP practice and certificates
Look for compliance with Good Manufacturing Practice and ask to see the certificates. WHO-GMP and ISO 9001:2015 are the ones buyers ask for most. Read the certificate itself: note the site address, the scope and the validity date. For more on what each one means, read WHO-GMP and ISO 9001:2015 explained.
3. In-house quality control
Ask what is tested inside the plant and what is sent to an outside lab. A manufacturer with its own HPLC and UV spectrophotometer can test raw materials and finished batches on site. Ask who does the testing and whether you can see a sample test report.
4. Experience with your dosage form
A plant that makes tablets every day is not automatically good at injections. Ask how long they have made your type of product and for examples of similar products they already produce.
5. Samples before you commit
You should approve a sample of the product, its specification and its packing before the first batch is made. Be careful with any manufacturer who asks for full payment before you have seen a sample.
6. Clear minimum order and lead time
Minimum order quantity and delivery time depend on the product and the dosage form. A good manufacturer gives you both in the quote and does not change them later without telling you.
7. A quote that shows what is included
Ask whether the price includes packing material, labels and cartons, testing and transport. Compare quotes line by line, not just the final figure.
8. Help with packing and artwork
Labels must carry the details the Drugs and Cosmetics Rules require, such as the manufacturer's name and licence number, the batch number, the dates and the price. Ask who checks your artwork against these rules before printing.
9. Easy communication
You will talk to this team for years. Notice how quickly they answer, whether they ask for missing details and whether one person owns your order.
10. Visit the plant
Nothing replaces a visit. Look at how material and people move through the plant, how clean the areas are and how orderly the records are. Gujarat's main highways make a day trip from Ahmedabad easy. Pulse Pharma's plant is in Himatnagar (Himmatnagar), roughly 75 to 80 km north of Ahmedabad.
Quick test: send the same brief to three manufacturers. The one that asks the best questions back usually understands your product best.
What to do next
Read how to write a manufacturing brief so every manufacturer quotes on the same facts. Then see how third-party manufacturing works at Pulse Pharma, or send us your requirement and we will reply with a quote.
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