JUST ABOUT PHARMA: May 2014

Wednesday, 28 May 2014

Book on Generic Drug product Development

Click here to view or download

Saturday, 24 May 2014

Frequently asked questions in Pharmaceutical QA Interview

Q. Brazil falls under which climatic zone ?

Q. According to WHO guidelines what is the storage condition of climatic zone IVa and zone IVb?

Q. What is dead leg?

Q. Brief about ICH stabilty guidelines?

Q. What is significant changes in stability testing?

Q. Why do we check hardness during inprocess checks?

Q. Which type of tablets are exempted from Disintegration testing?

Q. What needs to be checked during inprocess QA checks?

Q. In a tablet manufacturing facility ‘positive’ pressure is maintained in processing area or service corridors?

Q. If sticking observed during tablet compression what may the probable reason for the same?

Q. Why do we consider three consecutive runs/batches for process validation? Why not two or four?

Q. Why do we calibrate a qualified equipment/instrument on definite intervals?

Q. What needs to be checked during AHU validation?

Q. What is the difference between calibration and Validation?

CLICK HERE FOR ANSWERS AND SOME MORE QUESTIONS

Friday, 23 May 2014

OOS ( Investigating Out-of-Specification )

Guidance for Industry

Investigating Out-of-Specification (OOS)

Test Results for Pharmaceutical Production

I. INTRODUCTION

This guidance for industry provides the Agency’s current thinking on how to evaluate out-of-specification (OOS) test results. For purposes of this document, the term OOS results includes all test results that fall outside the specifications or acceptance criteria established in drug applications, drug master files (DMFs), official compendia, or by the manufacturer. The term also applies to all in-process laboratory tests that are outside of established specifications.

This guidance applies to chemistry-based laboratory testing of drugs regulated by CDER. It is

directed toward traditional drug testing and release methods. These laboratory tests are

performed on active pharmaceutical ingredients, excipients and other components, in-process materials, and finished drug products

to the extent that current good manufacturing practice(CGMP) regulations (21 CFR parts 210 and 211)and the Federal Food, Drug, and Cosmetic Act

(the Act) (section 501(a)(2)(B)) apply. The principles in this guidance also apply to in-housetesting of drug product components that are purchased by a firm.

This guidance can also be usedby contract firms performing production and/or laboratory testing responsibilities.Specifically,

the guidance discusses how to investigate OOS test results, including the responsibilities of

CLICK HERE TO VIEW COMPLETE GUIDANCE FOR OOS

Crystal chemistry book PDF

Physical Methods in Inorganic Chemistry

First Half: Crystallography

Textbooks

W. Massa/R. Gould: Crystal Structure Determination (Springer)

•

C. Giacovazzo(Ed.): Fundamentals of Crystallography

(Oxford University Press)

•

L. Bragg (Ed.): The Crystalline State (4 volumes)(Cornell University Press)

•

Kleber/Bausch / Bohm: Einführungin die Kristallographie

(VerlagTec)

CLICK HERE TO VIEW / DOWN LOAD THE BOOK

ANALYTICAL INSTRUMENT QUALIFICATION as per USP Gen Chapter

1058 ANALYTICAL INSTRUMENT QUALIFICATION

INTRODUCTION

A large variety of laboratory equipment, instruments, and computerized analytical systems, ranging from simple nitrogen evaporators to complex multiple-function technologies (see Instrument Categories), are used in the pharmaceutical industry to acquire data to help ensure that products are suitable for their intended use. An analyst's objective is to consistently obtain reliable and valid data suitable for the intended purpose. Depending on the applications, users validate their procedures, calibrate their instruments, and perform additional instrument checks, such as system suitability tests and analysis of in-process quality control check samples to help ensure that the acquired data are reliable. With the increasing sophistication and automation of analytical instruments, an increasing demand has been placed on users to qualify their instruments.

Unlike method validation and system suitability activities, analytical instrument qualification (AIQ) currently has no specific guidance or procedures. Competing opinions exist regarding instrument qualification and validation procedures and the roles and responsibilities of those who perform them. Consequently, various approaches have been used for instrument qualification, approaches that require varying amounts of resources and generate widely differing amounts of documentation. This chapter provides a scientific approach to AIQ and considers AIQ as one of the major components required for generating reliable and consistent data. Note that the amount of rigor applied to the qualification process will depend on the complexity and intended use of the instrumentation. This approach emphasizes AIQ's place in the overall process of obtaining reliable data from analytical instruments.

Click here to see 1058 Gen chapter in USPNF

Wednesday, 21 May 2014

Principle of Reversed-Phase Chromatography with animation

Principle of Reversed-Phase Chromatography with animation

Reversed-phase chromatography is all about the particle surface of the HPLC/UPLC column and the eluent solvent. The first slide shows a diagramatic view of the column with many small silica particles

Click here for principle-of-reversed-phase-chromatography-hplcuplc-with-animation/

Monday, 19 May 2014

SOPs FOR ALL DEPARTMENTS

This link is one of the best to create a SOP for any department like production, QC, QA etc.Its providing most information regarding content and template and arrangement of SOP.
Follow this link when you creating new SOP

CLICK HERE

Sunday, 18 May 2014

frequently asked interview questions in phrama interview

01.Q. Which type of tablets are exempted from Disintegration testing?

02.Q.What are the common variables in the manufacturing of tablets?

03. Q. Whether bracketing & validation concept can be applied in process validation?

04. Q. What is the difference between calibration and Validation?

05. Q. WHAT ARE GOOD MANUFACTURING PRACTICES (GMP)?

06.Q. WHO ENFORCES GOOD MANUFACTURING PRACTICES (GMP)?

07.Q.LIST OUT THE APPEARANCE DEFECTS OF TABLES DURING COMPRESSION ACTIVITY ?

08.Q What is the standard number of rotations used for friability test?

09.Q Which capsule is bigger in size - size '0' or size '1'?

And For more questions and Answers

c CLICK HERE pharma-interview-questions