[Pharma Digests]

Nicely explained @aid.

Can you share any authentic source of BCS database?

• This reply was modified 1 year, 5 months ago by .

[Pharma Digests]

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.

[Pharma Digests]

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 12 months ago by .

[Pharma Digests]

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.

[Pharma Digests]

– AssurX
– Veeva
– Intellect QMS
– ISOXpress
– Qualio etc.

[Pharma Digests]

Requirements with respect to data integrity in 21 CFR parts 11, 211 and 212:
– 21 CFR PART 211.68
– 21 CFR PART 211.100
– 21 CFR PART 211.160
– 21 CFR PART 211.180
– 21 CFR PART 211.188
– 21 CFR PART 211.194
– 21 CFR PART 212.110
– 21 CFR PART 212.60
– 21 CFR part 11

[Pharma Digests]

ICH E6 (R3) Guideline on good clinical practice (GCP)

[Pharma Digests]

Critical process parameters for Lyophilized Product Development:
– Freezing temperature
– Primary drying temperature
– Secondary drying temperature
– Time for annealing
– Pressure and time

[Pharma Digests]

Fundamental tests for pharmaceutical finished products:
– Identification
– Assay
– Dissolution
– CU/WV
– Impurity

[Pharma Digests]

Few critical check points for pharmaceutical manufacturing facilities to face FDA GMP audit:
– SOPs are up-to-date with practice
– Deviations and CAPAs
– Previous audit observations
– Data integrity
– Cleaning validation

[Pharma Digests]

To apply to market a new drug, biologic, or an antibiotic drug for human use (including NDA & ANDA), firstly you need to complete Form 356h.

Form 356h include: submission date, applicant information, product description, NDA/ANDA application number etc.

After successful filing your product, FDA will conduct application based GMP inspections to ensure the facility is capable of manufacturing the product consistently and that submitted data are accurate and complete.

[Author]

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