Interview Questions for Pharmaceutical industry related jobs (QA,QC,Production,RA,f&d) for B.pharma /M.pharma (Part 7)

GMP Question and Answers


Why is GMP important?
Poor quality medicines are not only a health hazard, but a waste of MONEYfor both governments and individual consumers.

Few qualification facts of Sterilization and Depyrogenation tunnel

Dry heat is used for sterilization instead of the much more efficient moist heat because some materials are sensitive to moisture. Dry heat is often used to ensure that glass and other laboratory equipment is free of pyrogenic material. The process of sterilization within a chamber or hot air tunnel is a critical process and there is a regulatory requirement for validation of the process in most countries. Validation is defined as the documented procedure of obtaining, recording and interpreting results to ensure that the dry heat sterilization process has been and will be consistently effective. Dry heat sterilizer validation consists of accurately measuring the temperature at critical points within the sterilization chamber throughout the process. Dry heat process generally employs a temperature between 250°C and 400°C for varying time. The sterilizer is required to heat all parts of its load up to the specified temperature for a specified period long enough to achieve the desired sterility.

Define re-test period of API and Excipients

Stability - Definition:

How the quality of an API or FPP varies with time under factors such as temperature, humidity and light.Studies also show how product-related factors influence stability: the properties of API/excipients, FPP composition, manufacturing process, and container-closure system.

API: Active Pharmaceutical Ingredient
FPP: Finished Pharmaceutical Products

Do's and Don'ts before giving Pharmacy registration to any Medical shop

Here we are providing the information that what are the precaution you need to be taken during giving any pharmacy registration and how to take relieving from medical shop. It is myself experience.

Acceptance Quality Level for Packaging Material and Printed Packaging Material

Definitions:
AQL: The AQL is the maximum percentage defective (or the maximum number of defects per hundred units) that can be considered satisfactory as a process average.
Nonconformity : Non fulfillment of a specified requirement
Defect: Non fulfillment of an intended usage requirement
 Nonconforming item: item with one or more nonconformity. 

Sampling Plan:
NORMAL inspection shall be initially.

AQL level consider as per (a) Critical Defects allowed: 0.1%, (b) Major defect allowed: 1.5% (c) Minor defects allowed: 2.5%.

Pharmacy syllabus need revisions

Among the health care professionals, pharmacists are considered as major pillars  in design, development and supply of quality medicines to the patients. The development of pharmaceuticals/formulations is an outcome of interplay between pharmaceutical and medicinal chemistry (especially synthetic and phytochemistry), pharmaceutics and pharmaceutical technologies, analytical techniques and quality

assurance at each and every level. Along with the basics of drug discovery and development, the advanced tools assisting developments of new drug substances and drug products are of paramount importance. Especially, high throughput screening techniques accelerate the pace of API/ excipient developments. The

pharmaceuticals which are being developed needs to be guaranteed high degree of quality assurance in it. Simultaneously, to meet the global and diverse needs one has to address requirements of both regulatory and non regulatory markets.

Design BMS (Building Management System) in Pharmaceuticals Industries

Building Management System (BMS) is monitor and control the parameters of HVAC system like temperature, relative humidity and air quantity to maintain a controlled environment.

Selection of Glass Vial Sterile Injectable product

Selection of Glass compatibility with drug product is major issue in Sterile Pharmaceutical practice. Physical and & Chemical stability is the major issue. Wrong selection of glass type caused breakages during Lyophilization, washing, DHS etc activity.

“ As per 21CFR211.94 Drug product containers and closures:

(a) Drug product containers and closures shall not be reactive, additive, or absorptive so as to alter the safety, identity, strength, quality, or purity of the drug beyond the official or established requirements.

(b) Container closure systems shall provide adequate protection against foreseeable external factors in storage and use that can cause deterioration or contamination of the drug product.”

Interview Questions for Pharmaceutical industry related jobs (QA,QC,Production,RA,f&d) for B.pharma /M.pharma (Part 6)

Few basic question ask during interview of fresher candidates (B.pharma /M.pharma) in HR round, so get ready and be prepared for interview 

1.      What is your aim in life?

  

2.      Who has inspired you in your life and why?

Qualifying Disinfection for Critical Environments and Cleanrooms

How are Disinfection Qualification Studies Regulated?

The success of disinfection procedures used in an aseptic manufacturing environment and the qualification of such processes to complying with GMP’s are not detailed in a simple guidance document. Although there is no harmonized protocol addressing the regulatory requirements associated with disinfection qualification studies, there are several approaches, principles and methodologies outlined in a variety of published sources. Such sources include USP chapters <1072> and <797>, ISO /DIS 14698-(1-3), ASTM E2614 and FDA’s Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing—Current Good Manufacturing Practice.

Safety is 1st priority

Safety is our main aim.

Don’t think life is a game.

Be alert open your mind-

Don’t be fool and act as blind.

Use proper tool by keep your mind cool,

Never being hurry and never being worry,

Prepare & prevent instead of repair & repent.

Remember!!

Accident Big or Small-

Let them avoid all.

Don’t forget those who are chance taker,

They are the actual accident maker.

Let learn, train & work

 Live life healthy & warm

Start Clean Room Qualification

Clean room practice is one of the toughest task in sterile pharmaceuticals. Now a days advanced HVAC system was designed to provide human comfort at working area and to maintain clean room requirement as per guidelines. Major regulatory guidelines now a days available with well define limits of viable and non viable for different grades (A,B,C,D). But practically it is initially very difficult to build up the practice in a new green field facility, where you have to establish the system in a proper way. Since cleaning is the major issue, Qualification study was designed,Standard Operating Procedure are prepared and personnel are trained accordingly. During study Clean rooms are observed with few parameters under At rest and as well as In Operation condition. 

THE TEN GOLDEN RULES OF GMP

1    Get the facility design right from the start

2    Validate processes

3    Write good procedures and follow them

4    Identify who does what

5    Keep good records

6    Train and develop staff

7    Practice good hygiene

8    Maintain facilities and equipment

9    Build quality into the whole product lifecycle

10  Perform self audits

Water System Design In Pharmaceutical Industry In Sterile Injectable Facility

1. PW Generation, Storage and Distribution System
2. WFI Generation, Storage and Distribution System
3. PSG Generation and Distribution System