What are the contents of Annual product quality review (APQR)?

Contents of an APQR is:

1.       Introduction

2.       Number of Intermediates and APIs batches produced

3.       Review of output for all Isolated Intermediates and Finished Products

4.       Review of Critical Quality attributes of In-process, Isolated Intermediates and Finished Products

5.       Summary of changes made during the year with respect to equipment, Process, Specifications, and Methods, Raw materials and others.

6.       List of Deviations and a brief description of deviations and action taken.

7.        List of customer complaints; Return goods and Recalled goods along with description and actions are taken.

8.       Number of Reprocessed and Reworks batches in all stages during the year-2009

9.        Review of Key starting materials and Primary packing materials and Rejections.

10.   Review of Bioburden on the product (for a minimum of 3 batches)

11.   Review on Stability studies and Summary

12.    List of Out of specifications for Finished products

13.   Review of Retained samples quality (Finished product)

14.   Review of Validation packages (Process, Equipment, Procedure)

15.   Status of Drug Master File (if any), Drug Master File new updates

16.    Details of special training provided to employees in case of Deviations or Complaints received regarding a particular product

17.   Summary Report

What are the different types of safety factors used in the pharmaceutical industries?

Following safety factors are used in pharmaceutical manufacturing.

•  1/10 to 1/100th of a normal daily dose = Topical products

•  1/100 to 1/1000th of a normal daily dose =     Oral products

• 1/1000 to 1/10000th of a normal daily dose = Injectable & Ophthalmic products

• 1/10000 to 1/100000th of a normal daily dose = Research, investigational products.

What is the solubility data as per any Pharmacopoeia?

Different products have different solubility levels. The solubility of the product is determined by dissolving in know volume of solvent.

•  Approximately volume of solvent in ml per gram of solute at 20° to 30°C
• Very soluble : Less than 1
• Freely soluble : From 1 to 10
• Soluble : From 10 to 30
• Sparingly soluble : From 30 to 100
•  Slightly soluble : From 100 to 1000
•  Very slightly soluble : From 1000 to 10000
• Insoluble / practically soluble : More than 10000

 Example:  Very soluble means one gram of solute substance will require less than 1 ml of solvent.

What is the necessity of analytical method validation?

The principle purpose of analytical validation is to ensure that a selected analytical procedure will give reproducible and reliable results that are adequate for the intended purpose. It is thus necessary to define properly both the conditions in which the procedure is to be used & the purpose for which it is intended.

 It means that analytical method validation is to prove that the analytical method used for analysis of the product works perfectly.

Define Bio burden?

The level & type (i.e. objectionable or not) of microorganisms that can be present in raw materials, API starting materials, intermediates or APIs. Bioburden should not be considered contamination unless the levels have been exceeded or defined objectionable organisms have been detected.

 It means the bioburden is the number microbes present in the raw material or water sample. Bioburden does not claim any specific microorganism.