The document outlines the importance and functions of manufacturing documentation in the pharmaceutical industry, emphasizing the need for information control, risk minimization, and compliance with regulatory requirements. It details the necessary documentation for various stages of production, including personal training, quality control, materials, and packaging, while highlighting the critical components of batch manufacturing records and master formula records. Overall, it asserts that proper documentation is essential for maintaining quality standards and legal compliance in good manufacturing practices.

1. Manufacturing Documentation
Mr. Sagar Kishor savale
[Department of Pharmaceutics]
avengersagar16@gmail.com
2015-2016
Department of Pharmacy (Pharmaceutics) | Sagar savale

2. Documents:
 Document is any written statement or proof.
 It is not just routine procedure it has its basic objective
of supplying information when required.
Sunday, May 29, 2016 2

3.  To define the manufacturer system of information and
control.
 To minimize the risk.
 To define the specifications and procedures for all
materials.
 To ensure that all personal concern with manufacture.
Sunday, May 29, 2016 3

4.  To ensure that authorized persons have all the
information.
 To ensure the existence of documented evidence.
 It ensures the availability of the data.
Sunday, May 29, 2016 4

5.  It helps the organization run.
 Improve information security function.
 Documenting information security procedures is
especially important.
Sunday, May 29, 2016 5

6.  Clear title.
 Identification number.
 Approval by authorized person.
 Date of issue
 Due date of revision.
 List to whom it has been issued.
Sunday, May 29, 2016 6

7. Documents required for:
 Personal training
 Quality control
 Factory
 Equipment
 Materials/stores
 Distribution
 Market complaint
Sunday, May 29, 2016 7

8.  For starting and packaging materials
 For intermediate and bulk products
 For finished products
Sunday, May 29, 2016 8

9.  Designated name and the internal code reference
 Reference, if any to a pharmacopoeial monograph
 The approved supplier and the original producer of the
material
 A specimen of printed material
Sunday, May 29, 2016 9

10.  Direction for sampling and testing
 Qualitative and quantitative requirements with the
acceptance
 Storage condition and precaution
 Maximum period of storage before re-examination
Sunday, May 29, 2016 10

11.  Should be available for critical steps or if these are
purchased or dispatched
 Should be similar to specifications for starting
materials or for finished product
Sunday, May 29, 2016 11

12.  Designated name and reference code
 Formula
 Description of the pharmaceutical form and package
details
 Direction for sampling and testing
 Qualitative and quantitative requirements
 Storage condition and any special handling precaution
 The shelf life
Sunday, May 29, 2016 12

13.  The purpose of this document to assure uniformity for
batch to batch
 Master formula record is a product specific document
compiled, checked, authorized, and approved by
competent technical personnel from different.
Sunday, May 29, 2016 13

14.  Patent/proprietary name of the product
 Pharmacopoeial/generic name of the product and its
strength.
 Dosage form and physical characteristic of the product
 Detailed information of product pack and primary
packaging materials.
 Identity, quality and quantity of every ingredient.
Sunday, May 29, 2016 14

15.  Batch manufacturing record is recurring document
 Batch manufacturing records primary replica of the
MFR
 It gives the actual process record of the batch
produced
 Help in maintaining the complete production and
control history of the batch.
Sunday, May 29, 2016 15

16.  It is a part of batch process record.
 Based on packaging instruction.
It includes following:
 The date and time of the packaging operation
 Name of the responsible person
 Initial of the operator
 In-process control checks and check made for identity and
conformation
Sunday, May 29, 2016 16

17.  Detail of packaging operation
 Sample of printed packaging material used, and
bearing the batch number, expiry date.
 Any deviation made, written authorization for the
same
 Quantity with identification of different packaging
materials issued, used, destroyed, returned to store
and reconciliation
Sunday, May 29, 2016 17

18.  Documentation is a integral part of good
manufacturing practices
 It consequently strengthens the quality and its
consistency of all goods and services as those
responsible for specific operation have clever
unambiguous instructions to follow including active
drug substances is legally mandatory.
Sunday, May 29, 2016 18

19.  Good Manufacturing Practice Medical Product for
Human and Veterinary published by European
Commission Health and Consumer Directorate
General, Belgium 2011.
 How to implement good manufacturing practices by
White Paper 2013.
Sunday, May 29, 2016 19