Docmentation complete

1. DEVELOPMENT OFDEVELOPMENT OF
PHARMACEUTICALDOCUMENTATIONPHARMACEUTICALDOCUMENTATION

2. Document is a written report or record that
provides information.
Documentation is a method of preparing a
written material, which describes the process
in terms of specifications ,instructions etc.

3. Document is a piece of written, printed or
electronic matter that provides information
or evidence.
A Good Documentation is essential part of
QA system .
Documentation is an important aspect in
pharmaceutical industry irrespective of the
fact the manufacturing plant is involved in
production of dosage form (or) active
ingredient.

4. Importance of documentationImportance of documentation
It provides the working details necessary for manufacturing,
packaging, quality control.
Reduce the risk of mistakes inherent in verbal communication.
They help in decreasing the batch to batch variation so that
quality of product is kept with in the limit of acceptability.
Documentation and records are essentials for obtaining
ACCREDIATION ,certification of ISO, and approval by Federal
bodies.

5. Aims of documentationAims of documentation
To define the specifications for all materials
To define the methods of manufacture and control
To instruct the personnel
To provide information during investigation
To helps in inspection or auditing by Regulatory
authorities.

6. WHY DOCUMENTATION :
•There is a saying in the pharmaceutical industry: 'if
it hasn't been documented, then it hasn't
happened!'
•Good documentation practice constitutes an
essential part of the QA system.
•Documentation system must be proactive vehicle
of communication.
“YOUR DOCUMENTATION IS AN
ADVERTISEMENT FOR YOUR WORK .
ˮ

7. To design an effective & efficient
documentation
• Identify the important characteristics of processing
event.
•The document directing the manufacturing event
fulfills current regulatory commitments to the agency;
it is appropriately written, reviewed and approved.
•The directive document is appropriate for the task to
be performed.

8. •The data is authentic, accurate, complete, legible,
accessible.
•The data collected fulfills expectations
(specifications) and is retrievable for review or
audit.
“All documentation should be legible, clean,
readily identifiable, retrievable and maintained
in facilities that provide a suitable environment
to minimize deterioration or damage and to
prevent loss”.

9. TYPES OF DOCUMENTS
Commitment Documents : Relationship between
industry and the regulatory authorities.
EX: New Drug Applications (NDAs), Drug Master Files (DMFs) etc.
Directive Documents : Relationship between the
Management and Employees.
EX: Specifications, STPs, Standard Operating Procedures (SOPs),
Medicinal Product Records (MPRs) etc.
Record Documents : Relationship between the Employees
and the Work they perform.
EX: Protocols, Batch Production Records (BPRs), Log Books,
Calibration Records etc.

10. Commitment Documents
•These present corporate goals, expectations and standard of

practice.
• It describes what to do.
• Consensus of purpose, direction and authorization for
projects.
• It organizes the work in a manner that assures efficient and
effective work flow.
• Commitments documents can also be written to establish
internal commitments. Written to lead and guide the work and
workers.

11. •These documents such as master plans; organize and
prioritize the work in a manner that supports good business
practice as well as regulatory compliance.
•To be used as active documents that are consulted and
followed routinely.
•Content must be consistent and rigorous in order to lead
and guide the work and the workers.
•Must describe the work as it will be done.
•Deviations from regulatory submissions can have
signification impact on product quality.
•Any deviation must be documented and managed.

12. • New Drug Applications (NDAs):
The New Drug Application (NDA) is the
vehicle in the United States through which drug
sponsors formally propose that the FDA approve
a new pharmaceutical for sale and marketing.

13. The goals of the NDA are to provide enough
information to permit FDA reviewers to establish
the following:
•Is the drug safe and effective in its proposed use(s) when
used as directed, and do the benefits of the drug outweigh
the risks?
•Is the drug’s proposed labeling (package insert)
appropriate, and what should it contain?
•Are the methods used in manufacturing (Good
Manufacturing Practice, GMP) the drug and the controls
used to maintain the drug’s quality adequate to preserve
the drug’s identity, strength, quality, and purity?

14. •Drug Master Files (DMFs):
Drug Master File (DMF) is a document
containing complete information on an Active
Pharmaceutical Ingredient (API) or finished drug
dosage form.
• The document provides the regulatory authority with
confidential, detailed information about facilities,
processes, or articles used in the manufacturing,
processing, packaging, and storing of one or more
human drugs.

15. • Drug Master File or DMF is a document prepared by a
pharmaceutical manufacturer and submitted solely at its
discretion to the appropriate regulatory authority in the
intended drug market.
• It is known as European Drug Master File (EDMF) or
Active Substance Master File (ASMF) and US-Drug Master
file (US-DMF) in Europe and United States respectively.
• The DMF contains factual and complete information on a
drug product's chemistry, manufacture, stability, purity,
impurity profile, packaging, and the cGMP status of any
human drug product.

16. •Directive Document:
•Working documents that establish the standards for
resources, processing, products & quality system.
•Describe how to do it……???
•Describe how to do routine work.
•Several types of directive documents.
•The different types are determined by the specific, functional
purpose of the document in the document system.
•In order to facilitate the development, production, testing and
distribution of a product in a defined manner.
•Reviewed and approved by both management and the
individuals responsible for performing the work.

17. •Specifications:
A document specification contains several parts:
 a description of the audience(s) for the document
 a detailed outline giving the structure and contents
of the document
 a work plan showing who is responsible for each
part of the document
 what the deadlines are for completing each task.

18. Three purposes for document
specifications:
In the workplace, formal document specifications
serve three important functions:
 economy of effort,
 work planning,
 writing organization.

19. Standard Operating Procedures (SOPs):
Standard Operating Procedures (SOPs) are issued
to specifically instruct employees in areas of
responsibility, work instructions, appropriate
specifications and required records
A Standard Operating Procedure (SOP) is a set of
written instructions that document a routine or
repetitive activity followed by an organization.

20. Record document:
Protocol:
 Protocols are written records clearly defining the objectives
and methods that will be used for the validation programs.
 An important part of the protocol is the description of the
testing method including who will test the system, how they
will test it and what data is to be collected and reported.
 Computerized system protocols often include the three
distinct stages as described in PMA reports: Installation
Qualification (IQ), Operational Qualification (OQ),and
Performance Qualification (PQ).

21. Protocol Changes
documented requirements specifying who and how
changes to parameters, thresholds, and acceptance
criteria are made after approval.
It is not impossible to make changes after or during
testing, but these changes must be properly
implemented and approved to be validatable.

22. What Good Documentation requires:
APPROVAL
CLARITY
REGULAR REVIEW AND UPDATE

FORMAL PRESENTATION

23. PROTOCOL FOR DOCUMENTATION
1.Serial number of the Batch Manufacturing Record.
2.Name of the product.
3.Reference to Master Formula Record.
4.Batch/Lot number.
5.Batch/Lot size.
6.Date of commencement of manufacture and date of
completion of manufacture.
7.Date of manufacture and assigned date of expiry.
8.Date of each step in manufacturing.
9.Names of all ingredients with the grade given by the
quality control department.
10.Quality of all ingredients.

24. 11. Control reference numbers for all ingredients.
12. Time and duration of blending, mixing, etc. whenever
applicable.
13. pH of solution whenever applicable.
14. Filter integrity testing records.
15. Temperature and humidity records whenever applicable.
16. Records of plate-counts whenever applicable.
17. Results of pyrogen and/or bacterial endotoxin & toxicity.
18. Results of weight or volume of drug filled in containers.
19. Bulk sterility in case of aseptically filled products.
20. Leak test records.
21. Inspection records.
22. Sterilization records including autoclave leakage test records,
load details, date, duration, temperature, pressure, etc.
23. Container washing records.

25. 24. Total number of containers filled.
25.Total numbers of containers rejected at each stage.
26. Theoretical yield, permissible yield, actual yield and
variation thereof.
27. Clarification for variation in yield beyond permissible
yield.
28. Reference numbers of relevant analytical reports.
29. Details of reprocessing, if any.
30. Name of all operators carrying out different activities.
31.Environmental monitoring records.
32. Specimens of printed packaging materials.
33. Records of destruction of rejected containers printed
packaging and testing.
34. Signature of competent technical staff responsible for
manufacture and testing.

26. STEPS IN PMD PROGRAMME
1.Identify at least two or more fairly knowledgeable
persons, one each from production and QC/QA who are
familiar with organization product .
2.List out manufacturing formulation departments existing
or planned .
3.List out the QC /QA ,engineering,warehousing,personnel
and other actives.
4.List out countries to which the product are likely to be
sold/distributied and collect the specific PMD
requirements .

27. 5. Categorization of documents should
be following
Documents for
personal training
QC/QA.
Building/factory
Equipment
Materials/stores
Engineering
Distribution.
Each category can be
split into following
SOP’s
Lists
Charts/formats
Specifications
Test methods
Reports

28. 6. Design the documents-considering the following
points
Contents
Formatting
Size and quality of paper etc.,.
7. Explain the document to people concerned
Train them in using the same
8.Trail run the documents, study the difficulties, modify
and redesign
9. Implement the document
10. Review by receiving feed back from the users at
regular intervals.

29. General requirementsGeneral requirements
Each document should have:
 Have a clear title
 Have an identification number
 Be approved by authorized person
 have the date of issue
 document should not be hand written
 Records should be retained at least one year
after the expiry date of the finished product

30. Designing of documents involves the following
factors :
 Size of the paper
 Color of the paper
 All four sides margin must be define generally 25
mm from left and 15 mm all sides
All documents must match the requirements
described in manufacturing and marketing
authorization.
All documents must bear the name of the company
and logo, if applicable

31. All documents must be approved, authorised,signed
and dated by the authorized person.
Title and contents of the documents must be self
explanatory.
Generally every document must be review every
two years or earlier.

32. When you design a document, run a dummy trail
of the document.
Users must be well trained in using a document
Normally all records must be stored for 1 year
after the shelf life of the product .

33. GMP GuidelinesGMP Guidelines
GMP guidelines specify certain documents to
be maintained necessarily:
1. Labels
2. Specifications and testing procedures
3. Records
4. SOPs

34. LabelsLabels
Labels are used for identification or status of
container, equipment and premises.
According to status of container the following
color labels are used

 Quarantine -- yellow
 Approved -- green
 Rejected -- red

35. Guidelines for labelsGuidelines for labels
Label of finished product contains
Name of the drug product
List of the active ingredients, qty
Net contents
Batch number
Expiry date
Storage conditions
Name and address of the manufacturer

36. Specifications and testing proceduresSpecifications and testing procedures
In case of pharmaceutical products we need
specifications for
Active and inactive starting materials
Primary ,printed and other packaging materials
Intermediate and bulk products
Finished pharmaceutical products

37. RecordsRecords
Various documents maintained in production
department are
Raw material records
Master formula records
Batch production records
Quality control records
Calibration records to instrument
Records for stability studies

38. Raw material recordsRaw material records
Schedule U shows the following particulars for raw material
records
Date of receipt
Invoice number
Name and address of manufacturer
Batch number
Quantity received
Pack size
Date of manufacture
Date of expiry
Quantity and date of issue

39. Master formula recordsMaster formula records
Master formula record are defined as written
procedures that give complete description of all
aspects of mfg, packing,& control with intention to
ensure the purity, identity quality & strength of the
product.

Master formula records should be prepared by
competent technical staff and should be reviewed
by the heads of production and quality control
departments

40. Master formula records should be described as
Follows
Name and strength of product along with dosage form
Complete list of all ingredients
Accurate statement of weight of each ingredient
A description of containers , closures , packaging
materials
A description of vessels equipment to be used in there
preparation.
Processing and packaging procedures
In process controls to be exercised during processing
and packaging

41. Quality control recordsQuality control records
QC records must show
Date of performance of test
Identification of material
Name of supplier
Date of receipt
Batch number
Quantity received
Quantity of sample taken
Statement of result of test
Signature of person who performs the test

42. Calibration records for instrumentsCalibration records for instruments
The procedure for calibration records must
include the following detail
Name of the instrument
Date of calibration
Reference standards used
Other reagents or tools used
Name and sign of the person who calibrated

43. Records for stability studiesRecords for stability studies
Procedure for stability study records
Name of product
Complete description of the packaging material
used
Period of time during which stability study has
been carried out
Condition in which product has been stored
during study

44. SOPSOP
 Sop is a defined as written documents
specifying the procedures that must be
followed to carryout operations
 The purpose of a SOP is to provide detailed
instructions on how to carryout task so that
any employee can carryout a task correctly
every time.
 SOPs are useful tools for training new
members of staff

45. SOP
Company Name and
Address:



Page No: X of Y
Title :



SOP No:
Revision No:
Review Period:
Prepared By Reviewed By Approved By





Scope

Responsibility


Procedure

46. ConclusionConclusion
It is concluded that good documentation is
everyone responsibility in the industry because
the quality ,safety, efficacy of the product will be
reflect on the documentation
Documentation is having its own importance in
the pharmaceutical industry and good
documentation leads to produce good quality of
products

47. Formulation development for global fillings
THE IMPACT OF WORLD REGULATIONS TO DEVELOP AND LAUNCH
HARMONIZED COSMETIC PRODUCTS
Business Strategy:
Since long time ago, we have been challenged:
“ How can we develop a cosmetic product that can have its inventory
ready to be exchanged around the globe.”
Same package with all information in
Same formula
“In other words: How to make one fit all”
Understand what is required in each country to sell cosmetics

48. R&D Process
• Product Development
• R&D systems should be able to provide to the Formulator
the ingredient’s regulation around the global/region so that
only approved ones can be used
• Product Safety
• Make sure that ingredients that are not regulated are
safe.
• Make sure that final formulation is safe
• Make sure claims are substantiated

49. Regulatory Affairs
 Make sure to update database system
• Ingredients update
• Safety test requirements
• Specific country/region product registration requirements
•Words/expression restriction / forbidden
•Claims requirements
•Unique requirements

50. Harmonized Product
•Last but not least
•Define Manufacturing strategy
•This will drive the last regulatory requirements to
have harmonized product:
•Same package
•Same formula
•Same label copy
•Approved in the countries according strategy

51. The impact of world regulation to develop and launch
harmonized cosmetic products
 Time to launch harmonized product is too long impacting:
•Marketing strategy
•Supply Chain strategy
•Adding Premium costs
•Service issues

52. ReferencesReferences
Guidelines on cGMP and quality of pharmaceutical
products by “S.IYER “
cGMP for pharmaceuticals by “ MANOHAR A
POTDAR “
 Pharmaceutical production and management by “
CVS SUBRAMANYAM”