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Post History: Chief Pharmacist
@sayeed
Moisture sensitive products require high barrier packaging and desiccant inclusion. Thus, y …In: Packaging mode for moisture sensitive products
10 months ago
@sayeed
You can prepare a study plan and execute it.
For your easiness you can follow this: https: …In: NAPLEX
10 months ago
@sayeed
You can check it - https://www.pharmaspecialists.com/2023/01/fda-inspection-database.htmlIn: FDA Warning Letter
10 months ago
@sayeed
You should check the below points:
Granules size: for smaller tablet large granules and …In: Compression Problem
10 months ago
Solid dispersion refers to the dispersion of one or more active ingredients in a hydrophilic inert c …In: Advanced Granulation Techniques
10 months ago
Here is the list of discussion topics of 21 CFR Part 211:
https://www.pharmaspecialists.com/2022/09 …In: Discussion Topics of 21 CFR Part 211
10 months ago
You can follow the below equation:
OEE = Availability × Performance × Quality
More details ava …In: Overall Equipment Effectiveness (OEE) Calculation
10 months ago
@ard
You can go through the below topics:
Here is a list basic learning topics for a Analytical Sc …In: Analytical Job Preparation
10 months ago
Here is a list basic learning topics for a Analytical Scientist:1. Analytical Feasibility Checklisth …In: Analytical Development Study
10 months ago
FDA Approves COBENFY with New Mechanism of Action for Treatment of Schizophrenia.
“Schizophrenia …In: FDA Approve New Drugs 2024
11 months ago
FDA Approves First Nasal Spray Neffy for Treatment of Anaphylaxis
"FDA approve the first epi …In: FDA Approve New Drugs 2024
11 months ago
You can see the below article:
https://www.pharmaspecialists.com/2021/09/selection-of-dissolution-m …In: Dissolution Media
11 months ago
As a formulation development scientist you should have good understanding on below topics (but not l …In: Formulation Development Study
11 months ago
A list of advanced granulation techniques used in pharma industry:
Hot melt extrusion (HME)
Foam …In: Advanced Granulation Techniques
11 months ago
FDA Approves First Treatment Miplyffa (arimoclomol) for Niemann-Pick Disease, Type C
“NPC is a se …In: FDA Approve New Drugs 2024
11 months ago
FDA Approves Nasal Spray Influenza Vaccine "FluMist" for Self- or Caregiver-Administration …In: FDA Approve New Drugs 2024
11 months ago
FDA Approves Aqneursa (levacetylleucine) to Treat Niemann-Pick Disease, Type C
“This is the secon …In: FDA Approve New Drugs 2024
11 months ago
The List of FDA Approve New Drugs 2024:
Flyrcado (flurpiridaz F 18)
Cobenfy (xanomeline and tros …In: FDA Approve New Drugs 2024
11 months ago
@ard
The two common causes of peak splitting in HPLC are a blocked frit and a void in the packing a …In: Peak Splitting in HPLC
11 months ago
As per WHO statement,
More than 100 countries have incorporated the WHO GMP provisions into their n …In: WHO GMP Audit
11 months ago
I refer to below article containing regulatory inspection checklist:
https://www.pharmaspecialists. …In: EU vs FDA Audit
11 months ago
As per FDA, the dissolution media selection should be based on formulation properties, solubility of …In: Dissolution Media
11 months ago
@ard
Following parameters to be evaluated during analytical method validation:
Precision
Accura …In: Key Parameters for Method Validation
11 months ago
@iqbalsikder
You can consider one batch with proper risk assessment.In: No. of batch for Cleaning Validation
11 months ago
@iqbalsikder
There is no specific number of runs for cleaning validation. It should be based on ris …In: No. of batch for Cleaning Validation
11 months ago
@iqbalsikder
There is no specific number of runs for cleaning validation. It should be based on ris …In: No. of batch for Cleaning Validation
11 months ago
@ard
Following points should be considered during method development (but not limited to):
From th …In: Method Development Challenges
11 months ago
@frd
As per your statement 100% overage is required for target wt. gain. You should consider also f …In: Coating Solution Calculation
11 months ago
@sayeed
As a part of ANVISA audit preparation following areas should be prioritized:
HVAC system …In: ANVISA Audit Preparation
11 months ago
@sayeed
There are a lot of reasons for getting 483 from FDA. I mentioned here few:
SOP violation …In: FDA Warning Letter
11 months ago
@sayeed
Category-2 is related to firmware. At the time that GAMP4 was issued firmware was considere …In: GAMP 5
11 months ago
Medsafe is the New Zealand Medicines and Medical Devices regulatory authority. While TGA approval ca …In: TGA Audit
11 months ago
You can check the below link:
https://www.pharmaspecialists.com/2022/11/fda-inspection-checklist.ht …In: FDA Inspection Checklist
11 months ago
FDA and EU regulations concerning clinical research, manufacturing and quality, and post-marketing s …In: EU vs FDA Audit
11 months ago
Major areas to be checked before FDA inspection (but not limited to):
Practice inline with SOP
…In: FDA Inspection Checklist
11 months ago
Category 1 - Infrastructure Software (includes operating systems, database management systems, and n …In: GAMP 5
11 months ago
A reference listed drug (RLD) is the listed drug identified by FDA as the drug product which is refe …In: RLD and RS
11 months ago
