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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 1 year, 4 months ago by .
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@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@FRD
Liquid nitrogen is one of the safest cooling agents for pharmaceutical use. It can ensure extremely low temperature, which is required for freeze drying in lyophilization process.Liquid nitrogen also offer a wider processing window to added flexibility and productivity benefits.
- This reply was modified 1 year, 6 months ago by .
@FRD
You can reduce the debossing/imprinting code or you can omit it with proper justification.@FRD
Following factors are critical for BCS based biowaiver:
– Solubility of highest single therapeutic dose
– Type of Dosage Form
– Composition of Drug Product
– Mode of administration
– Comparative in vitro dissolution tests etc.Stringent Regulatory Authority
The World Health organisation (WHO) classifies a stringent regulatory authority (SRA) as a national drug regulatory authority that applies stringent quality standards, safety, and usefulness in its regulatory assessment of medicines and vaccines for marketing approval. The approval by the SRA is an indication of the product’s high degree of efficacy and safety.Less Stringent Regulatory Aauthority
A national drug regulatory authority that applies flexibiity in its regulatory assessment of medicines and vaccines for marketing approval in respect to quality standards, safety, and usefulness.In the European Union (EU), there are two main routes for authorising medicines: a centralised route and a national route.
Under the centralised authorisation procedure, pharmaceutical companies submit a single marketing authorisation application to EMA.
This allows the marketing-authorisation holder to market the medicine and make it available to patients and healthcare professionals throughout the EU on the basis of a single marketing authorisation.
EMA’s Committee for Medicinal products for Human Use (CHMP) or Committee for Medicinal products
for Veterinary Use (CVMP) carry out a scientific assessment of the application and give a recommendation on whether the medicine should be marketed or not.Once granted by the European Commission, the centralised marketing authorisation is valid in all EU Member States as well as in the EEA countries Iceland, Liechtenstein and Norway.
If a company wishes to request marketing authorisation in several EU Member States for a medicine that is outside the scope of the centralised procedure, it may use one of the following routes:
– the mutual-recognition procedure, whereby a marketing authorisation granted in one Member State can be recognised in other EU countries;
– the decentralised procedure, whereby a medicine that has not yet been authorised in the EU can be simultaneously authorised in several EU Member States.As per ACCP, Clinical pharmacists:
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– Assess the status of the patient’s health problems and determine whether the prescribed medications are optimally meeting the patient’s needs and goals of care.
– Evaluate the appropriateness and effectiveness of the patient’s medications.
– Recognize untreated health problems that could be improved or resolved with appropriate medication therapy.
– Follow the patient’s progress to determine the effects of the patient’s medications on his or her health.
– Consult with the patient’s physicians and other health care providers in selecting the medication therapy that best meets the patient’s needs and contributes effectively to the overall therapy goals.
– Advise the patient on how to best take his or her medications.
– Support the health care team’s efforts to educate the patient on other important steps to improve or maintain health, such as exercise, diet, and preventive steps like immunization.
– Refer the patient to his or her physician or other health professionals to address specific health, wellness, or social services concerns as they arise.- This reply was modified 1 year, 7 months ago by .
