Welcome to Pharma Topics Forums
The largest online community for industrial pharmacists.

Forum Navigation
Post History: Chief Pharmacist
You can do risk assessment considering:
Molecule stability data
Product stability data
Product …In: Manufacturing Area RH & Temperature excursion allowable time
2 weeks ago
There is another course on pharma lesson for pharmacist licensure exam preparation:
https://courses …In: Study Materials
3 months ago
5 months ago
@ariyan
You should prioritized below topics:
ALCOA+https://www.pharmaspecialists.com/2022/02/alc …In: QA Job Preparation
5 months ago
You can find here:
https://courses.pharmalesson.com/course-tag/certification-course/In: Pharmacy Course
5 months ago
Basic learning topics for QC job seekers:
1. QC Equipment Listhttps://www.pharmaspecialists.com/202 …In: QC Job Preparation
6 months ago
I think, you may want to know about peak vessel. It is used to overcome the coning problem arise dur …In: Dissolution Vessel Size
6 months ago
Discriminating dissolution media used to identify the differences in the dissolution performance of …In: Discriminating Dissolution Media
6 months ago
Dissolution vessels come in various sizes, although the standard size is 1 litre. Other available si …In: Dissolution Vessel Size
6 months ago
HPLC calibration parameters typically include:A. Pump1. Flow Rate Accuracy2. Flow Rate Consistency3. …In: HPLC Calibration
7 months ago
1. ISO 9001 – Quality Management System (QMS)2. ISO 14001 – Environmental Management System (EMS)3. …In: ISO Guidelines
7 months ago
You can follow the health Canada guidance:
https://www.canada.ca/en/health-canada/services/drugs-h …In: Critical Parameter of Cleaning process
8 months ago
A visual inspection is performed after a cleaning operation at dried condition of the equipment and …In: Rinse sampling for Cleaning validation
8 months ago
BASICS RULES OF GLP
1) Make sure to have the correct written procedure/instructions before starting …In: GLP
8 months ago
I hope below contents will be helpful:
Key Elements of a Bioequivalence Study Strategy
Bioequiva …In: Bioequivalence Study
8 months ago
I hope below article will be helpful for you -
https://pharmadigests.com/basic-guideline-for-promet …In: DHA & MOH
8 months ago
Check the below link:
https://pharmaexams.com/formulation-development-interview-questions-and-answe …In: Formulation Development Job Preparation
8 months ago
Hi @ariyan,
Please find the below source of free online pharmacy courses:
https://courses.pharmadi …In: Pharmacy Course
8 months ago
You can check the below topics:
1. Good Design Practicehttps://www.pharmaspecialists.com/2023/10/go …In: Pharmaceutical Manufacturing Study Topics
8 months ago
Drug-layer coating is usually performed for such products which are showed incompatibility in conven …In: Drug Layer Coating
8 months ago
Half-life is useful for determining excretion rates as well as steady-state concentrations for any s …In: PK Parameters for BE Study
8 months ago
You can check the below database:
https://www.pharmaspecialists.com/p/available-bcs-classificatio …In: BCS Classification Database
8 months ago
Major areas of R&D can be inspected:
Analytical method transfer & validation area
Stabil …In: FDA Audit in R&D
8 months ago
You can follow the below topics:
1. Good Design Practicehttps://www.pharmaspecialists.com/2023/10/g …In: Pharmaceutical Production Job Preparation
9 months ago
Optimum spray rate, inlet temperature and product temperature can reduce the loss of API during drug …In: Drug Layer Coating
9 months ago
Common DI issues in pharma:
Backdating
Data is not legible
Overwriting
Wrong data
Data missi …In: Common DI Issues
9 months ago
Usually following parameters are measured in bioequivalence study:
AUC(0-t)
AUC(0-∞)
Cmax
tmax …In: PK Parameters for BE Study
9 months ago
Please find the below FDA guidelines regarding ANDA:
ANDA Submissions — Amendments to Abbreviated …In: FDA Guideline for ANDA Submission
9 months ago
@ariyan
Refer to below articles:
Formulation Development Strategy for BCS Class I Molecules
For …In: Preformulation Study
9 months ago
You can check it: https://pharmaexams.com/pharmaceutical-production-interview-questions-and-answers/ …In: Pharmaceutical Production Job Preparation
9 months ago
A sample of the rinse or swabbing solvent should always be based on the type of testing to be perfor …In: Suitable Diluent selection for swab & rinse sampling
9 months ago
EDQM = European Directorate for the Quality of Medicines & HealthCare.
The EDQM contributes to …In: EDQM
9 months ago
Here is the details guideline:
https://cdn.who.int/media/docs/default-source/medicines/norms-and-st …In: WHO Guideline for Technology Transfer
9 months ago
List of ICH Q Guidelines:
ICH Q1A(R2) – Stability Testing of New Drug Substances and Products
IC …In: ICH Q Guidelines
9 months ago
In general, “significant change” for a drug product is defined as:
A 5% change in assay from its …In: Stability Study
9 months ago
@ariyan
Refer to below articles:
Formulation Development Strategy for BCS Class IV Molecules
So …In: Preformulation Study
10 months ago
Refer to below article:
https://www.pharmaspecialists.com/2023/02/dissolution-specification-setting …In: EMA Guideline for Dissolution
10 months ago
Here is a checklist for facing EU audit:
1. Job Training2. Quality Policy3. Good Housekeeping Progr …In: EU Audit Checklist
10 months ago
There are four types of FDA inspection:
Pre-Approval Inspections
Routine Inspections
Follow-up …In: Types of FDA Inspection
10 months ago
@ariyan
You can check the below points (not limited to):
Document control system
In-process con …In: FDA Audit Preparation
10 months ago
@ard
Common sources of dissolution method:
BP/US Monograph
FDA Dissolution Database
SBOA
& …In: Dissolution Method
10 months ago
10 months ago
To take the NAPLEX, you must be completed graduation on pharmacy school accredited by the Accreditat …In: NAPLEX
10 months ago
@ariyan
You can consider below points:
PURPOSE
SCOPE
RESPONSIBILITIES
TRAINING REQUIREMENTS
…In: SOP Contents
10 months ago
You can verify the calculatuon here: Cleaning Validation Acceptance Criteria Calculation
I …In: Problem in MACO Calculation of Micro dosage form
10 months ago
You can check the below contents:
https://www.pharmaspecialists.com/2023/02/dissolution-specifica …In: Dissolution Specification
10 months ago
Possible HPLC Columns Problems:
Peak tailing due to frit blockage, a column void, sample interact …In: HPLC Chromatography Problems
10 months ago
@sayeed
A List of Guidelines on Data Integrity:
Data Integrity and Compliance With CGMP
PIC/S G …In: Data Integrity Guidelines
10 months ago