2. OBJECTIVE
The objective of this presentation to emphasis
the importance of documentation
for
industries and describe
the protocols
regarding this also their management.
3. DOCUMENT & DOCUMENTATION
•Document is written statement of proof
The document can
Assure that quality standards are consistently met.
Communicate these standards all who interact with
project.
A Document System is an interacting set of documents,
each with a defined purpose and consistent document.
4. TYPES OF DOCUMENTS
Commitment Document
Relationship between industry and the regulatory
authorities.
Directive document
Relationship between management and employee
Record document
Relationship between the employee and the work
they perform.
5. DOCUMENTATION is a process that involve the systematic
interaction of people, events and document to create the records
of the organisation/corporate
Documentation is the key to GMP compliance and ensures
traceability of all development, manufacturing, and testing
activities. Documentation provides the route for auditors to
assess the overall quality of operations within a company and the
final product.
6. THE 10 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 regular audits
7. LIST OF THE MOST COMMON TYPES OF
DOCUMENTS USED FOR GMP
DOCUMENT
DESCRIPTION
Quality
manual
A global company document that describes, in paragraph form, the
regulations and/or parts of the regulations that the company is
Required to follow
Policies
Documents that describe in general terms, and not with step-by-step
instructions, how specific GMP aspects (such as security,
documentation, health, and responsibilities) will be implemented.
(SOPs)
Step-by-step instructions for performing operational tasks or
activities.
Batch Records
These documents are typically used and completed by the
manufacturing department. Batch records provide step-by-step
instructions for production-related tasks and activities, besides
including areas on the batch record itself for documenting such
tasks.
8. Test methods
These documents are typically used and completed by the quality
control (QC) department. Test methods provide step-by-step
instructions for testing supplies, materials, products, and other
production-related tasks and activities, e.g., environmental
monitoring of the GMP facility. Test methods typically contain forms
that have to be filled in at the end of the procedure; this is for
documenting the testing and the results of the testing.
Specifications:
Documents that list the requirements that a supply, material, or
product must meet before being released for use or sale. The QC
department will compare their test results to specifications to
determine if they pass the test.
Logbooks
Bound collection of forms used to document activities. Typically,
logbooks are used for documenting the operation, maintenance, and
calibration of a piece of equipment. Logbooks are also used to record
critical activities, e.g., monitoring of clean rooms, solution
preparation, recording of deviation, change controls and its
corrective action assignment.
9. OBJECTIVE & IMPORTENCE OF
DOCUMENTATION
OBJECTIVE• Define the manufacturer’s information system and control
strategies clear.
•Minimises the risk of misinterpretation and errors.
•Confirmation of task performed.
•Tracing the batch history of any product
IMPORTENCE• Good documentation is an essential part of quality assurance
system and must be as requirement of GMP.
•Define the specifications of each product
•Ensure the quality
• Ensures that the responsible authorities, have knowledge of
the work carried out.
11. INCLUSIONS OF DOCUMENTATION
Revised schedule M has the following elements which are
related to documentation:---- Records
Labels
Specifications And Testing Procedures
Master Formulae
Packaging Instructions
Batch Production and Control records (BPCR) / Batch
Manufacturing Records
Batch Packaging Records (BPR)
Standard Operating Procedures (SOPs)
11
12. Introduction
In pharma industry, Labels are used for identification and/or status of
container, equipment and premises.
Labels should be unambiguous and in format approved by the company.
Sometimes colored labels are used to indicate status. For Example, colored
labels for starting materials according to their status:
Quarantine
Yellow
Approved
Green
Rejected
Red
12
13. Label of finished product
• Name of product
• Ingredients
• Net Content
• Batch number
• Expiry date
• Storage condition
• Information about manufacturing company (Lice. No. and Address)
13
14. Label of reference standard
• Name of material
• Potency
• Date of preparation
• Batch number
• Shelf-life
• Storage condition
14
15. • Introduction
• Specifications for Raw Materials
• Specifications for Finished Product
• Specifications for Packaging Materials
• Testing Procedures
HNSIPER
15
16. INTRODUCTION
It is a list of detailed requirements with which product/material
used or procedure followed during manufacture need to
conform.
They serve as basis for quality evaluation.
Specifications should be available for :
• Raw Materials
• Finished Products
• Packaging Materials
First twos can be referred from their individual monographs
from pharmacopoeia.
If standard data is not available in pharmacopoeia, then
manufacturer can write specification himself.
Specifications for packaging materials such as plastic or glass
containers and closers etcetera, are not given by any
monograph. However certain requirements have been laid down
for them in appendix-11 of I.P.
16
17. Bureau of Indian Standards (BIS) has prepared
specifications for various packaging materials.
These specifications are given prefix as “IS”, means
‘Indian Standard’.
There are 18210 numbers of Indian Standards.*
Certain specifications amongst them are specifically
prepared for pharmaceutical industry, while the rest
are general specifications.
17
18. SPECIFICATIONS FOR RAW MATERIALS
Generic and chemical name of material
Trade name or product code established any manufacturer
Description
Name of pharmacopoeia or any other recognized book of
standards in which monograph appears or INN
(International Non-proprietary Name).
Approved supplier
Frequency of testing of stored material
Special precautions to be taken during storage including
safety aspects
Date of Issue of specifications
18
19. SPECIFICATIONS FOR FINISHED PRODUCT
Generic name of product
Trade name
Dosage form and Strength
Description (Color, State, Dimension, Taste)
Physical properties ( Weight/Volume (with limit), pH,Viscosity,
Density, Hardness, Friability, Disintegration time, Dissolution Time
etcetera)
Name of Pharmacopoeia as a reference
Date of Expiry
Precautions during storage including safety aspects
Date of issue of specification
19
20. SPECIFICATIONS FOR PACKAGING MATERIALS
Below mentioned Indian standards may referred,
while preparing specifications for packaging materials:
Number of IS
Specification for
IS 7803
Plastic Containers
IS 3692
Rubber Closures
IS 1776
Folding Box Board
IS 2771
Corrugated Box
IS 3101
Collapsible Tubes
IS 7852
Eye Ointment Tubes
IS 10133
Glass Bottles
IS 8970
Paper Aluminum Foil
IS 8393
Pilfer Proof Closures
IS 1984
Glass Vials
20
21. TESTING PROCEDURES
These are nothing but the procedures for testing raw
materials, intermediated and finished products.
These procedures are basically based on Pharmaceutics
and Analytical techniques.
While preparing these procedures Various pharmacopoeia
(like IP, BP, JP, EP, USP etc) and other recognized books of
standards like drug and cosmetics rules, USNF, other
authoritative books on analysis of drugs.
21
22. FORMAT FOR STANDARD TESTING PROCEDURE
Name :
Pages:
Code No. :
Shelf Life :
Status :
Effective Date :
STP No. :
Review Period :
Prepared By
Checked By
Approved By
Signature
Date
22
24. Definition
Master formulae also can be said and written as ‘Master
Formula Record’, ‘Manufacturing Formula’, ‘Master
Production and Control Record’ (MPCR) etcetera.
It is defined as “An approved master document that describes the full
process of manufacturing for the batch of specific
product.”
It includes all the materials used in any batch
manufacturing and step by step process of manufacturing.
24
25. PREPARATION OF MATER FORMULAE
Master formulae can be prepared by competent
technical staff.
It should be reviewed by the heads of production,
quality control department and research &
development.
25
26. Description
Name and Strength of the product along with dosage form
MFR No.
A complete list of all ingredients with their quantity
Description of Containers, Closures and Packaging materials to
be used
Description of all Vessels and Equipments used in the process
Processing and Packaging Instructions
IPQCs to be exercised during processing and packaging
Precautions to be taken during manufacture and storage of semifinished product including any special storage conditions
Reference
26
29. Definition
Batch Processing Record can also be said as Batch
Manufacturing Record (BPCR) .
It is defined as –
“The Batch Manufacturing Record (BPCR) is the
necessary quality and GMP documentation for
tracing the complete cycle of manufacture of a
batch or lot.”
29
30. CONTENTS OF BPCR
The name and batch number of the product
Dates and times of commencement, of significant intermediate stages and
of completion of production
Identification (initials) of the operator(s) who performed each significant
step of the process and, where appropriate, the name of any person who
checked these operations
Quantities of each starting material actually weighed
A record of the in-process controls and the initials of the person(s)
carrying them
The product yield obtained at different and pertinent stages of
manufacture
Notes on special problems including details, with signed authorization for
any deviation from the Manufacturing Formula and Processing
Instructions
Approval by the person responsible for the processing operations.
30
32. INTRODUCTION
In fact, BPR is a part of BPCR.
These records are based on packaging instructions.
One important operation that should be carried out before
packaging operation is line purging (clearance).
32
33. CONTENTS OF BPR
Name, Batch number and Qty. of bulk finished product to be
packed
Theoretical and Actual Yield and Reconciliation
The date and time of the packaging operation
The name of responsible person and his initials
Details of packaging instructions like equipments and
packaging lines used
Qty. along with identification of different printed packaging
materials issued, used, destroyed and/or returned to store
and reconciliation
In any case of problems, if any deviation made, written
authorization for the same
33
35. INTRODUCTION
Site Master File is a document, which gives a complete
information regarding a site of pharmaceutical plant.
This document generally should not be very massive,
like running into more than 100 pages.
M.H.R.A. (Medicines and Healthcare products
Regulatory Agency), a government agency of U.K., has
given certain guidelines for length of the format for it.
35
36. INCLUSIONS OF SMF
The Information about Company
Personnel
Premises and Equipment
Documentation
Production
Quality Control
Contract manufacture and analysis
Distribution, Complaints and Product Recalls
Regulatory inspections and self-inspections
Details of Annual Product Review
Change Control System
Technical Quality Agreement for Contract Manufacturing
(Technical Agreement, Quality Agreement)
36
38. Sub-part A-General Provision
Sub-part B•Responsibilities of QC unit
•Available facility of QC unit
•List of critical instruments
•Quality control manual
•Training manual
•Attendance records of trainee
•Training evaluation records
•List of employees
•Organogrammes
•Job description
•SOP on appropriate clothing and protective apparels.
•SOP on practice of good sanitation and health habits.
•SOP on entry procedures to factory and various department.
•SOP on pre & post employment medical check-up of employees.
•Records of consultants.
39. Sub-part C
•Statement of formulation & their volumes
•Plans of the facility
•Area specifications of building, facilities.
•SOP on buying & facility cleaning and sanitation
•SOP on building & facility maintenance
•SOP on maintain of environmental condition
•SOP on cleaning & disinfection of aseptic areas & equipments.
•Statement of lighting requirements in the facility
•HVAC system
•Plumbing diagram
•SOP on sewage and refuse handling
•Diagram of washing and toilet facilities.
•SOP on pests, rodent, birds, insects and vermin control
•Job description of sanitary inspector
40. Subpart D•Equipment description list
•Equipment M.O.C. List
•SOP on cleaning, operation & maintenance of each and
every identified equipment.
•SOP on records of calibration
•List of filters for injectables.
41. Subpart –E
•SOP on receipt and storage of R.M./P.M.
•List of RM/PM with their storage
•SOP on sampling of RM/PM
•SOP on tasting and approval or rejection of materials
•SOP on re-testing of approve material.
•SOP on handling of rejected materials.
•List of primary packaging materials and their composition.
•SOP on testing of closure system.
•SOP on cleaning, sterilization and depyrigenating the container and
closures.
•SOP and record on vendor certification.
42. Sub-Part-F
•SOP on change control procedure
•SOP on dispensing of batch materials.
•List of critical phases of operation where yield should be
checked.
•Equipment identification record
•SOP on sampling and testing of in process materials.
•SOP on time limitation on production.
•SOP on validation of sterilization process.
•SOP on reprocessing of materials
43. Sub-Part G
•SOP on receipt identification, storage, handling, sampling, examination
testing of labelling & packaging materials.
•SOP on issue of printed packaging materials
•SOP on IPQC during packaging and labelling operation
•SOP on expiration dating.
Sub-Part-H
•SOP on quarantine of finished products before release by QC.
•SOP on storage of finished products under appropriate condition of
temperature, humidity and light.
•SOP on distribution of finished products.
44. Sub-part I•Written specification
•SOP on calibration
•SOP on validation
•SOP on stability testing
•SOP on special testing requirements
•SOP on reserve samples
•Records of laboratory animals
•SOP on penicillin contamination
45. Sub-part J
•Equipment cleaning, use and maintenance log
•Material receiving record
•Results of examination and testing of materials
•Material inventory record
•Records of disposition of rejected materials
•Master production and control record.
•Batch production and control record
•Production record review.
•QC laboratory record should have all the
documents listed in 211.194 distribution record.
•SOP on complaints and their reports/records.
46. Sub-part K
•SOP on handling of returned product.
•SOP n handling of salvaging.
48. USE OF MAINTENANCE RECORDS
The use of maintenance records is particularly important in
a factory setting, where a large number of expensive
machines are used daily.
These records can help make sure that any appropriate
equipment maintenance or plant maintenance has been
completed so that plant operations will run smoothly.
For instance, a maintenance log detailing any repairs or
service upkeep may be kept on a factory machine. This log
can help avoid accidents or plant shut-downs resulting
from defective equipment
48
49. MAINTENANCE RECORD MANAGEMENT
Maintenance record management can be important for a
number of reasons: Good records help department managers and employees
ensure that a piece of equipment is performing in line with
any manufacturer warranties.
Maintenance records also help companies track when a
piece of equipment needs to undergo preventive
maintenance. If a company gets sued in relation to a faulty
piece of equipment, maintenance records can be essential
in supporting the company's case.
49
51. RECORD KEEPING
Records provide history of a batch
1. Name and address of supplier of each drug product with date
2. Name and address of purchaser of each drug product with
date
3. Supplier or purchaser licensed
4. Retention of order forms, copy of delivery notes, stores
receipt, and issue vouchers ,and book of records (controlled
drugs book/prescription drugs book) on the premises as
provided for in the drug laws.
5. Accuracy of records kept.
51
52. PURPOSE AND PRINCIPLE OF RECORDS
Scientific
Regulatory requirement
Business purpose
Maintenance of Records is the essential part of quality
assurance system
Records must be free from errors
52
53. RETENTION OF RECORDS
Records should be kept in such a way that activities
concerning the production and quality control of active
pharmaceutical ingredients are traceable.
Records should be retained for at least one year after the
expiry of the finished product or for a specified period if
there is no expiry date.
53
54. RECORDS MAINTENANCE
The functions of records maintenance include the following
essential components:
Organizing and filing records
Identifying which records to retain, and for how long
54
55. CONCLUSION
Documentation is necessary in pharmaceutical industry
Documentation is a key area for companies in the
pharmaceutical industry. The United States Food and Drug
Administration (FDA)-the governmental agency, that is
responsible for overseeing the industry, requires extensive
documentation for every manufacturing and packaging lot of
all pharmaceutical products.
The FDA mandates documentation for the sake of
accountability and traceability.
This practice is to ensure safe and effective pharmaceutical
products.
