INDUSTRIAL DOCUMENTATION

1. DOCUMENTATION
IN PHARMACEUTICAL INDUSTRY

2. CONTENT
 DEFINATION : DOCUMENT
 CHARACTERISTICS
 OBJECTIVES OF DOCUMENT
 CLASSIFICATION OF DOCUMENT
 LAYOUT OF DOCUMENT
 TYPES OF DOCUMENT

3. DEFINATION
DOCUMENT IS INFORMATION (MEANIMFUL
DATA) AND ITS SUPPORTING MEDIUM , IN THE
FORM OF PAPER , CD ,COMPUTER FILE
,MICROFILE ETC.
DOCUMENT PROVIDE INFORMATION OR
EVIDENCES OR MAY SERVE AS AN
OFFICIAL RECORD .

4. CHARACTERISTICS
 DOCUMENT HAVE A CLEAR TITLE
 IT HAVE AN IDENTIFICATION NUMBER
 IT SHOULD APPROVED BY AUTHORISED PERSON
 HAVE THE DATA OF ISSUE
 HAVE A DUE DATE OF THE REVISION
 THE INSTRUCTION SHOULD BE PRECISED AND NOT
AMBICIOUS
 SUFFICIENT SPACE SHALL BE PROVIDE FOR MAKING EACH
ENTRY
 HEADING SHALL CLEARLY INDICATE WHAT IS TO BE MADE
BY PERSON USING DOCUMENT
 ALL ENTRIES SHALL BE IN INK

5.  ALL ENTRIES SHALL BE CLEAR
 PERSON MAKING THE ENTRIES SHALL CONFIRM
THE ENTRY BY SINGNING THE NAME
 IF DOCUMENT IS THROUGH ELECTRONIC DATA
PROCESSING SYSTEM , THERE SHALL BE
ADEQUATE , RELIABLE SYSTEM IN PLACE :
 : - TO CHECK AND ENSURE CORRECTNESS OF
DATA
 :- TO RECORD CHANGES (ADDITION / DELATION)

6. OBJECTIVES OF DOCUMENT
 DEFINES SPECIFICATION AND PROCEDURE FOR ALL
MATERIALS AND METHODS OF MANUFACTURER AND
CONTROL
 ENSURE ALL PERSONEL KNOWS WHAT TO DO AND WHEN TO
DO IT
 ENSURE AUTHORISED PERSONS HAVE ALL INFORMATION
,NECESSARY FOR RELEASE OF PRODUCT
 ENSURE DOCUMENTED EVIDENCE , TRACABILITY PROVIDE
RECORDS AND AUDIT FOR INVESTIGATION
 ENSURE AVAILABILITY OF DATA OF VALIDATION REVIEW AND
STATASTICAL ANALYSIS

7. CLASSIFICATION OF DOCUMENT
CLASSIFICAT
ION
PERONEL
EQUIPMENT
MATERIALS
PROCESSING
FINISHED
GOODS
COMPLAINTS
BUILDINGS
AND
PREMISES

8.  BUILDINGS AND PREMISES : INSTALLATION ,
VALIDATION ,CLEANING AND MAINTAINANACE .
 PERSONEL : TRAINING , HYGIENE ETC.
 EQUIPMENTS : INSTALLATION , CALIBRATION ,
VALIDATION , MAINTAINACE , CLEANING .
 MATERIALS : SPECIFICATION , TESTING ,WAREHOUSING
, REJECTION /DISPOSAL.
 PROCESSING : INDIVIDUAL STEPS IN THE PROCESS OF
MANUFACTURING INCLUDING CONTROLS THERE OF .
 FINISHED : SPECIFICATION ,TESTING ,STORAGE
,DISTRIBUTION .
 COMPLAINTS: INVESTIGATION AND ACTION.

9. LAYOUT OF DOCUMENT
 COVERPAGE WITH IDENTITIES AND STATUS.
 TABLE OF CONTENT
 SCOPE AND APPLICABILITY SECTION
 INTRODUCTION
 INFORMATION AND INSTRUCTION IN LOGICAL
SEQUENCE
 ADDITIONAL INFORMATION AND DETAILS

10. TYPES OF DOCUMENT
TYPES
SPECIFICATION
INSTRUCTIONS
BATCH
DOCUMENTATION
PROCEDURES
AND RECORD
SOP’S
TEST METHODS
LIST
CERTIFICATE OF
ANALYSIS

11. SPECIFICATIONS
 THE DESIGNATED NAME OF THE PRODUCT AND
THE CODE REFERENCE WHERE APPLICABLE
 THE FORMULA OR SUITABLE REFERENCES
 A DESCRIPTION OF THE PHARMACEUTICAL
FORM AND PACKAGE DETAIL
 DIRECTION FOR SAMPLING AND TESTING OR A
REFERENCE TO PROCEDURES
 THE STORAGE CONDITION AND ANY SPECIAL
HANDLING PRECAUTIONS
 SHELF – LIFE

12. INSTRUCTIONS
ALL INSTRUCTION TO THE PERSONEL
SHOULD BE CLEAR ,PRECISE ,AMBICIOUS AND
WRITTEN IN NUMBERED STEP THEY SHOULD
BE WRITTEN IN LANGUAGE AND STYLE THAT
USER CAN READILY UNDERSTAND
ASSOCIATED WITH INSTRUCTION ARE
REORDS .
THIS CAN BE EITHER COMBINE WITH
THE INSTRUCTION IN THE SEPARATE
DOCUMENT.

13. BATCH DOCUMENTATION
 NAME OF PRODUCT ,GENERIC NAME , STRENGTH
,SHELF LIFE ,MFG.DATE , EXP.DATE .
 A COMPLETE LIST OF INGRIDIENT WITH FULL
DISCRIPTION CODES AND QUANTITY TO BE ISSUED
 A STATEMENT FOR PROCESSING AND EQUIPMENT
 DATES AND TIME OF ALL ACTIVITIES
 LINE CLEARANCE PROCEDURE IN EVERY STEP
 LABELING CONTROL AND SPECIMEN FOR CODING IN
PRIMARY, SECONDARY AND TERTIARY PACKAGING
MATERIALS

14. PROCEDURES AND
RECORDS
IN ADDTION TO THE INSTRUCTION AND ASSOCIATED
RECORDS DESCRIBES ABOVE , SPECIFIC PROCEDURES ,
INCLUDING MATERIAL RECIPT , SAMPLING , TESTING ,
REJECTION COMPLAINTS AND OTHER DOCUMENTS ARE
ALSO REQUIRED , DEPENDING ON THE TYPES OF
DOCUMENT ,GMP EXPECTATION ARE THAT DOCUENT
CARRIES :
- PRODUCT NAME
- PACK OR BATCH SIZE
- NAME OF ASSOCIATED PERSONEL
- DATES AND TIMES , VERSION NUMBER
- APPROVAL

15. SOP’S
IT IS WRITTEN AUTHORISED FUNCTIONAL INSTRUCTION USED
AS REFERENCE BY THE PERSON RESPONSIBLE FOR
PERFORMANCE AND ARE ALSO USED FOR THE TRAINING NOW
OPERATORS IN THE PERFORMANCE OF THE PROCEDURE.
TEST METHOD
IT IS A METHOD AND APPROVAL DOCUMENT DESCRIBES THE
DETAILED TESTING PROCEDURES.
LIST
DOCUMENTS CONTAIN A CATLOG OF ANY OBJECT SUCH AS LIST
OF EQUIPMENT.
CERTIFICATE OF ANALYSIS
IT IS AN AUTHENTIC DOCUMENT WHICH SHOWS THE ANALYTICAL
SPOTS AND DECISION OF ACCEPTANCE /REJECTONS.

16. REFERENCES
 www.pharmatutor.org
 www.researchgate.com

17. Thank you !