Qvents

Qvents

Discussion forum for Pharma Quality events, Regulatory Actions

Warning letters, 483s, Recalls, Import Alerts, Audit observations

The Guidelines page guides you to important GMP and Regulatory guidance’s; Provides links to published final and draft guidelines of regulatory authorities like USFDA, EMA, WHO, MHRA, TGA and other NRAs. The page provides links to guidance’s and scientific discussion papers by expert bodies and technology platforms like ISPE, PICS, APIC, USP.

Guidance’s, literature and scientific discussion papers are collated subject wise to help navigate quickly to relevant document. Scroll over the titles to know which guidelines and topics are listed under the title. Click on + to open the list.

API DMF (Drug Master File) #A
#DMF

Ayurveda, meaning “science of life” in Sanskrit, is one of the world’s oldest systems of medicine, originating in India over 3,000 years ago. It is a holistic healing practice that emphasizes the balance between the body, mind, and spirit to maintain health and prevent disease.

At the core of Ayurveda is the belief that each individual is made up of five elements: earth, water, fire, air, and ether.

These elements combine to form three life energies or doshasVata (air and ether), Pitta (fire and water), and Kapha (earth and water).

Cleaning Validation
Computer systems validation (CSV), Electronic Data Controls
Controlled Correspondence / Scientific Advice with regulatory agencies
Data Integrity 1
dsad
Educational #OOS
Excipients related
Field Alert Reports (FAR-USFDA); Europe Rapid Alerts ; Europe Informing National Competent Authority (NCA)
GMP Good Manufacturing Practices – Medicinal Products and Active Pharmaceutical Ingredients (APIs)
Guidelines Testing

Testing guideline 1

Guideline for testing 2

Life Style #Acceptable Intake
Manufacturing Date and Expiry Date
may 14 test
  • asdsadsad
  • asdsadsad
Nitrosamines
Pharmacovigilance
Posted by test mar 14
  • fdfdfsadf

fsafadf

Process Validation
Qualified person (QP) and Batch release related
Quality by Design (QbD) Design of Experiments (DOE)
Quality Risk Management (QRM)
Recalls
Reserve Samples / Retention Samples
Role of Herbal Medicines in Health #Advisory Actions
  • These remedies are commonly used in traditional systems like Ayurveda, Traditional Chinese Medicine (TCM), and Unani.
  • One of the main advantages of herbal medicine is that it often has fewer side effects compared to synthetic drugs, especially when used correctly.
Rounding off, Statistics
sdsd

reasd

tesasd

Shared Facilities / Dedicated Facilities requirements
Site Master File (SMF)
Specifications and Tests
ss

teest

Stability & Hold time studies

Hold time studies:

Standards (Reference standards, Working standards)
Sterile Manufacturing
Stratified Sampling – Content Uniformity (CU) / Uniformity of dosage units; Blend Uniformity (BU);
tasadfsad

sadsad

test apr 23 #A

tesadsadsa

Test may 20
Test may13
  • test123
  • test 345
Test new guideline
Water- All you want #Acceptable Intake (AI)
Water system