[Pharma Digests]

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.

[Pharma Digests]

@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 Qualification

3. Production and Process Controls
– Standard Operating Procedures (SOPs)
– Process Validation
– In-Process Controls
– Batch Records

4. 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 results

5. Packaging and Labeling
– Label Control
– Packaging Integrity
– Expiry Dating

6. Documentation and Recordkeeping
– Batch Records
– Deviations
– Change Control
– Training Records

7. Self-Inspection and Audits
– Internal Audits
– CAPA Managements

8. Complaint Handling and Recall Procedures

9. Data Integrity
– ALCOA+ Principles
– Electronic Records

10. Quality Risk Management (QRM)

[Pharma Digests]

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.

[Pharma Digests]

It’s level 3 changes.

[Pharma Digests]

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/

[Pharma Digests]

Here involves statistical analysis to determine if the method meets the required standards for accuracy, precision, and other parameters.

[Pharma Digests]

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.

[Pharma Digests]

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.

[Pharma Digests]

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)

[Pharma Digests]

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.

[Pharma Digests]

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 impact

For 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/

[Pharma Digests]

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.

[Pharma Digests]

You can check the below article:
https://pharmaexams.com/clinical-pharmacist-interview-questions-and-answers/

• This reply was modified 8 months ago by .

[Pharma Digests]

The monograph test method is generally recommended, but it is not mandatory. You can go with alternative method with following considerations:
– Method is developed based on scientifically sound principles
– Method is validated

[Pharma Digests]

@FRD
You should consider the following parameters for RMG process scale up:
– Impeller Tip Speed
– Inlet Air flow for Drying
– Milling speed of Dried Granules

[Author]

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