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1) production
2) facilities and equipment
3) laboratory controls
4) materials
5) packaging and labeling
6) quality management- This reply was modified 1 year, 8 months ago by .
Following FBP parameters you can remain same/similar in both R&D and Production scale:
– Inlet air temperature
– Product temperature
– Atomization nozzle sizeAnd you should adjust the below parameters:
– Inlet air flow
– Spray rate
– Atomization air pressureYes, FDA requires for any solid dosage drug products of prescription or OTC be it tablets or capsules to have imprint code for product identification and to prevent fraud.
– It should be a unique identification of the drug product and the manufacturer or distributor of the product.
– It can be any single letter or number or any combination of letters and numbers.
– This is applicable for solid oral dosage form drug product.- This reply was modified 1 year, 9 months ago by .
You can follow the below equation-
A = πr^2Where,
A= cross sectional surface area (m^2)
r= radious of the bottom screen (m)As per clinical pharmacology and biopharmaceutics review of Zithromax, Azithromycin fall in BCS class I or III.
Ref.: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/50-784_zithromax_biopharmr.pdf
@FRD
As far I know there is no major challenges in analytical method of Valsartan + Amlodipine Tablets. You can follow USP method.@FRD
This guideline is a basement of QbD approach. But there is a lot of guidelines and practical courses are available now.Roller compaction or slugging process is better for manufacturing of Valsartan + Amlodipine Tablets.
Nicely explained @aid.
Can you share any authentic source of BCS database?
- This reply was modified 2 years, 2 months ago by .
Bekow things should also include for a new GMP facility:
– Records and Reports
– Sanitation condition
– HVAC system
– Raw material sourcing
– Internal audit and compliance etc.Here is the list of most stringent regulatory authorities:
1. US FDA
2. EMA (European Union)
3. ANVISA (Brazil)
4. Health Canada
5. TGA (Australia)
6. PMDA (Japan)
7. SAHPRA (South Africa)
8. NPRA (Malaysia)
9. NPMA (China)
10. HSA (Singapore)It may slightly vary based on the cGMP practice and clinical study requirements.
- This reply was modified 1 year, 8 months ago by .
Very similar.
– Community pharmacists supply prescribed and over-the-counter medicines to the general public.
– Retail pharmacists fill medication orders placed by doctors for customers who come into their pharmacy.
