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Here is a bundle of GxP certification courses – https://courses.pharmalesson.com/course-bundle/gxp-certification-courses-for-pharmacist/
- This reply was modified 2 weeks, 5 days ago by .
Both the EU and the FDA aim to ensure that pharmaceutical products meet the highest standards of quality, safety, and efficacy, thereby protecting public health. However, there are some differences in their regulatory frameworks, focus areas, and inspection processes.
Such as, EU strongly emphasis on quality risk management (ICH Q9) and quality systems but FDA strongly focus on data integrity, process validation, and compliance history.
@FRD
Areas under FDA GMP (Good Manufacturing Practices) inspection:
1. Facility and Equipment
– Facility Design (layout, space, cleanliness)
– Equipment design, maintenance, calibration, and cleaning
– Utilities (qualification of water systems, HVAC, and other utilities critical to production)2. Materials Management
– Proper sourcing, testing, and storage of raw materials
– Tracking and reconciliation of materials
– Supplier Qualification3. Production and Process Controls
– Standard Operating Procedures (SOPs)
– Process Validation
– In-Process Controls
– Batch Records4. Quality Control and Testing
– Adequate testing of raw materials, in-process materials, and finished products
– Established quality standards for materials and products
– Evidence that products remain within specifications throughout their shelf life
– Proper handling and investigation of OOS results5. Packaging and Labeling
– Label Control
– Packaging Integrity
– Expiry Dating6. Documentation and Recordkeeping
– Batch Records
– Deviations
– Change Control
– Training Records7. Self-Inspection and Audits
– Internal Audits
– CAPA Managements8. Complaint Handling and Recall Procedures
9. Data Integrity
– ALCOA+ Principles
– Electronic Records10. Quality Risk Management (QRM)
As per EMA guideline in following scenarios lower strength can consider:
1. If the highest strength cannot be administered to healthy volunteers for safety/tolerability reasons. for example: antipsychotic drugs
2. If the pharmacokinetics of the drug is non linear, that means AUC doesn’t increase in proportion to dose administered, and if there is less than proportional increase in AUC due to saturation of uptake mechanism and there are no excipients that alter GI motility or transport proteins.
Do let me know if you know any other situations when BE is acceptable only on the lower strength.
Second scenario is a little complicated to understand, just do a little research to understand it better.
Clinical study requirements for an Investigational New Drug (IND) application are designed to ensure the safety and efficacy of the investigational drug during human trials. Here are the key aspects and requirements:
– Clinical Study Protocol
– Informed Consent
– Good Clinical Practice (GCP)
– Safety Reporting
– Institutional Review Board (IRB) Approval
– Clinical Trial Registration
– Data Monitoring Committee (DMC)For details: https://pharmadigests.com/fda-clinical-study-requirements-for-ind/
Here involves statistical analysis to determine if the method meets the required standards for accuracy, precision, and other parameters.
The critical factors regarding bi-layer tablet:
– The ratio of the wt. of two layers
– Particle size of the granules
– Tablet hardness and friability
– Meet the Weight variation and CU specification etc.Both supplier and monograph method will get preference for raw material analysis. As prior analysis method should be validated, therefore supplier method followed at first as a validated method.
Here is the components of GxP:
1. Good Manufacturing Practice (GMP)
2. Good Laboratory Practice (GLP)
3. Good Clinical Practice (GCP)
4. Good Pharmacovigilance Practice (GVP)
5. Good Documentation Practice (GDP)
6. Good Distribution Practice (GDP)Most common DI issues in Pharma:
1. Backdating of Postdating
2. Difference between raw data and recoded data
3. Data hidden
4. Inconsistencies in Data
5. Access by Unauthorized Individuals etc.Based on the impact of proposed change, change control can be categorized as below:
– Minor Change: Low impact
– Major Change: Significant impact
– Critical Change: High impactFor details refer to:
1. https://pharmadigests.com/types-of-change-control-in-pharmaceutical-industry/
2. https://industrialpharmacist.com/2024/12/change-control-management-a-systematic-approach/To qualify as a community pharmacist in UK, you must:
– complete a General Pharmaceutical Council (GPhC)-accredited Masters degree in pharmacy (MPharm)
– complete a period of one-year paid pre-registration training in a GPhC-approved community pharmacy, under supervision
– pass the GPhC registration assessment
– meet the GPhC fitness to practice requirements for registration as a pharmacist.To qualify as a community pharmacist in USA, you need:
– a PharmD degree from an accredited educational institution in order to practice as a pharmacist in the community setting.
– a Bachelor’s degree in Pharmacy or its equivalent, as long as all of the intern and/or experiential hours are met before applying for a pharmacist license.You can check the below article:
https://pharmaexams.com/clinical-pharmacist-interview-questions-and-answers/- This reply was modified 8 months, 3 weeks ago by .
