Skip to main content

Featured post

🧠 Steps in ICSR (Individual Case Safety Report) – A Complete Journey of Ensuring Patient Safety

Post a Comment

Pharmaceutical Production Interview Questions & Answers

Pharmaceutical Production Basics: BMR, BPR, SOP, GMP & In-Process Checks

Understanding key pharmaceutical production concepts is important for students, fresh graduates, and professionals working in pharmaceutical manufacturing. Below are essential terms used in tablet compression, capsule filling, coating operations, and quality documentation within the pharmaceutical industry.


1. What is Production?

Production in the pharmaceutical industry refers to the complete process of manufacturing a product, starting from the receipt of raw materials to the final dispatch of the finished product. It includes:

  • Handling and verification of raw materials
  • Manufacturing and packaging operations
  • Proper documentation and batch record maintenance
  • Managing manpower and ensuring compliance with procedures

2. What is Batch Manufacturing Record (BMR)?

A Batch Manufacturing Record contains the complete documented history of a product batch during production. It includes:

  • Material dispensing records
  • Granulation, blending, compression, capsule filling and coating steps
  • Signatures of operators and supervisors
  • Date and time of each activity

3. What is Batch Packaging Record (BPR)?

A Batch Packaging Record documents all packaging activities performed on a batch, such as:

  • Blister packing
  • Bottle or jar packing
  • Carton and shipper packing
  • Operator and supervisor signatures for verification

4. What is Active Pharmaceutical Ingredient (API)?

An Active Pharmaceutical Ingredient is the component responsible for the therapeutic effect of a medicine. It produces pharmacological action for treatment, diagnosis, or prevention of disease.

5. What is Standard Operating Procedure (SOP)?

A Standard Operating Procedure is an approved document that describes step-by-step instructions for performing specific activities. SOPs ensure uniformity, compliance, safety, and quality in production and packaging processes.

6. What is GMP and CGMP?

GMP (Good Manufacturing Practices) are guidelines that ensure pharmaceutical products are consistently produced and controlled to required quality standards.

CGMP (Current Good Manufacturing Practices) refers to following the latest and updated GMP standards as regulatory requirements evolve.

7. In-Process Checks During Tablet Compression

  • Appearance / Presentation
  • Group and Individual Weight Variation
  • Thickness and Diameter
  • Hardness and Friability
  • Disintegration Time
  • Compression Force and Machine Speed

8. In-Process Checks During Capsule Filling

  • Appearance
  • Group and Individual Capsule Weight
  • Net Fill Weight
  • Capsule Locking
  • Disintegration Time

9. In-Process Checks During Tablet Coating

  • Appearance
  • Inlet and Outlet Temperature
  • Spray Rate and Gun Distance
  • Weight Gain
  • Coated Tablet Group & Individual Weight
  • Tablet Thickness

10. Common Tablet Defects

  • Weight variation
  • Picking and adhering
  • Capping and lamination
  • Chipping and breakage
  • Double compression
  • Rough edges or powdery surface
  • Black spots, oil stains, foreign particles
  • Incorrect embossing or debossing

This information is widely used in pharmaceutical plant operations and is helpful for job interviews, production training, and GMP understanding.


Labels:

Comments

Post a Comment

If you have any doubts , please let me know .

Popular posts from this blog

Wipro Hiring: Case Processing Associates (Pharmacovigilance)

  Wipro Hiring: Case Processing Associates (Pharmacovigilance) – Pune Wipro is Hiring: Case Processing Associates (Pharmacovigilance) – Pune Wipro is inviting applications from Pharmacy, Nursing, and Life Science graduates for Case Processing Associate roles in Pharmacovigilance (PV) . Role Highlights Job Title: Case Processing Associate (Pharmacovigilance) Location: Pune Work Mode: Onsite (Work From Office) Shifts: General / Rotational Eligibility: B.Pharm / Nursing / BDS / BMS / Life Sciences Experience: Freshers to 4 years Who Can Apply This role is ideal for candidates who: Hold a degree in B.Pharm, Nursing, BDS, BMS, or Life Sciences Are freshers or have up to 4 years of relevant experience Are comfortable with onsite work and general/rotational shifts  Key Responsibilities (Typical for PV Case Processing) Collect, review, and process individual case safety reports (ICSRs) Ensure completeness, accuracy, a...
Post a Comment
Read more

Top Pharmacovigilance Interview Questions and Answers (Fresher to Experience)

Title: Pharmacovigilance Interview Questions and Answers Define Pharmacovigilance Pharmacovigilance is the science of collecting, monitoring, researching, evaluating, and interpreting data from healthcare professionals and patients about the adverse effects of medicines, biological products, herbal treatments, and other medical substances. The purpose is to ensure drug safety and protect public health. What Are the Minimum Criteria Required for a Valid Case? A valid safety case must contain: • An identifiable reporter • An identifiable patient • A suspect product • An adverse drug event Define Adverse Drug Event (ADE) An Adverse Drug Event is any undesirable medical occurrence that happens after the administration of a pharmaceutical product, regardless of whether it is related to the drug. Define Adverse Drug Reaction (ADR) An Adverse Drug Reaction is a harmful, unintended response to a drug that occurs at normal doses used for diagnosis, treatment, or prevention of...
Post a Comment
Read more

Clinical Research Associate (CRA) Jobs – CBCC Global Research | Delhi, Bengaluru, Pune, Kolkata

CBCC Global Research is hiring experienced and enthusiastic Clinical Research Associates (CRAs) to support innovative oncology and non-oncology clinical studies across India. Locations Delhi • Bengaluru • Pune • Kolkata What You’ll Bring 1–4 years of on-site monitoring experience in clinical trials Strong understanding of GCP , ICH guidelines , and regulatory processes Excellent communication and organizational skills Willingness to travel for site monitoring visits Why Join CBCC Global Research Work on cutting-edge oncology and non-oncology studies Collaborative, growth-oriented environment Competitive compensation with strong learning opportunities How to Apply Send your updated CV to sonu.gupta@cbcc.global with the subject line: Application – CRA – [Your Name] – [Preferred City] About CBCC Global Research CBCC Global Research partners with leading investigators and institutions to deliver high-quality clinical research with patient-centric...
Post a Comment
Read more