The document outlines the importance and structure of documentation in the pharmaceutical industry, emphasizing its necessity for compliance with regulatory guidelines, maintaining quality control, and ensuring traceability of processes. It details various types of documents, including quality manuals, standard operating procedures (SOPs), and master formula records, alongside the characteristics and lifecycle of effective documentation. Additionally, the document discusses the auditing process, specification criteria, and distribution record requirements to facilitate efficient quality management systems.

1. QUALITY CONTROL AND
QULAITY ASSURANCE
ADITHYA K
II SEM M PHARM
MPA203T

2. TOPIC
DOCUMENTATION IN PHARMACEUTICAL INDUSTRY
- QUALITY REVIEW
- QUALITY DOCUMENTATION
- SPECIFICATION AND TEST PROCEDURES
- PROTOCOLS AND REPORTS
- DISTRIBUTION RECORDS

3. CONTENTS
DOCUMENTATION
 INTRODUCTION
 NEED OF DOCUMENTATION
 OBJECTIVES OF DOCUMENTATION
 SCOPE OF DOCUMENTATION
 TYPES OF DOCUMENTATION
 CHARACTERISTIC OF DOCUMENT
 DOCUMENTATION REVIEW
 DOCUMENTS MODELS
 FOUR TIERS OF DOCUMENTATION ACC TO ISO 9001
 SOPs
 MASTER FORMUAL RECORD
 QUALITY AUDIT PLAN AND REPORTS
 DOCUMENTATION AND COMMUNICATION
 SPECIFICATION AND TEST PROCEDURES
 PROTOCOLS AND REPORTS
 DISTRIBUTION RECORDS

4. DOCUMENTATION
INTRODUCTION :
• What is documentation ?
documentation is any communicable material that is used to
describe, explain or instruct regarding some attributes of an object,
system or procedure, such as its parts, assembly, installation,
maintenance and use.
Documentation provides both ;
1. Information on when, where, who, why and how to complete tasks.
2. Evidence providing that the tasks have been completed as they
should be.

5. NEED OF DOCUMENTAITON
1 Mandatory as per regulatory guidelines
2 Keep track of activities
3 Evidence to face legal issues
4 Maintains a historical record

6. OBJECTIVES OF DOCUMENTAITON
 To define the specifications and procedures for all materials,
method of manufacture and control.
 To ensure that all personnel concern with manufacture know
what to do and when to do it.
 To ensure that authorized persons have all the information
necessary to decide whether or not to release a batch of a drug
for sale.
 To ensure the existence of documented evidence, trace ability,
and to provide records and an audit trail that will permit
investigation.
 It ensures the availability of the data needed for validation,
review and statistical analysis.

7. SCOPE OF DOCUMENTAITON
Good documentation encompasses practically all the aspect of
pharmaceutical production.
• Building and premises: installation, validation, cleaning, and
maintenance
• Personnel: training, hygiene etc.

8. SCOPE OF DOCUMENTAITON
• Equipment : installation, calibration, validation, maintenance,
cleaning.

9. SCOPE OF DOCUMENTAITON
• Materials : specification, testing, ware-housing, disposal.
• Processing: individual steps in the process of manufacturing.
• Finished goods: specifications, testing, storage, distribution,
and rejection/ disposal.

10. DOCUMENTATION LIFECYCLE
DESIGN
COMPOSITION
REVISION
APPROVAL DISTRIBUTION TRAINING
UTILIZATION
MAINTAIENENCE
REVISION
ANALYSIS AND DEFINITON
OF REQUIREMENTS
ABROGATION
PREPARATION DIFFUSION
USE
UPDATING

11. DOCUMENT
QUALITY
MANUAL
POLICIES
SOPs
BATCH
RECORDS
TEST
METHODS
SPECIFICATI
ONS
LOGBOOKS
TYPES OF DOCUMENTS

12. TYPES OF DOCUMENT
 QUALITY MANUAL : A quality manual is a top level document that
describes an organizations Quality management system (QMS). It
can be used both internally (for employees) and externally (for
customers and auditors).

13. TYPES OF DOCUMENT
 LOG BOOK : all companies are required to keep a logbook for the
chronological documentation of equipment- related events such as
validation and qualification work, calibration, equipment cleaning
preventive maintenance and repairs and unexpected events/
deviations for manufacturing equipment, apparatus, quality
control and IPC analytical equipment and utilities.

14. TYPES OF DOCUMENT
 SOPs : is a set of step by step instructions compile by an
organization to help workers carry out routine operations.
SOPs aim to achieve efficiency, quality output and uniformity
of performance, while reducing miscommunication and failure
to comply with industry regulations.

15. TYPES OF DOCUMENT
 BATCH RECORD : the batch record is a product quality
controlled document that collects all the data and information
to make a regulated product. Batch records record materials,
equipment, people, data, labels, and events during the
production of products.

16. CHARACTERISTIC OF DOCUMENT
For effective use of documents, they should be designed and prepared with
utmost care. Each document shall;
(i) Have a clear title.
(i) Have an identification number.
(ii) Be approved by authorized person.
(iii) Have the date of issue.
(iv) Have a due date of revision.
(v) List to whom it has been issued.

17. DOCUMENTATION REVIEW
• Documentation system should provide for a periodic
review and revision if necessary of any document or part
there of .
• Such revised versions shall also be approved by the
authorized persons.
• Updated/revised versions shall also be superseding the
previous edition, and the document shall clearly indicate
this.
• Outdate/superseded document shall be immediately
removed from active use, and copy retained only for
reference.

18. “DOCUMENTS” MODEL
D = Design, development, deviations, dossiers and drug master files for regulated
markets, distribution records
O = Operational procedures/ techniques/ methods, out of specifications (OOS), out
of trend (OOT).
C = Cleaning, calibration, controls, complaints, containers and closures,
contamination and change control.
U = user requirement specifications, utilities like water systems, HVAC, AHU etc.

19. “DOCUMENTS” MODEL
M = Man, materials, machines, methods, maintenance, manufacturing
operations and controls, monitoring, master formula, manuals, medical
records.
E = Engineering control and practices, Environment control, Equipment
qualification documents.
N = Non-routine activities, new products and substances.
T = technology transfer, training, testing, trend analysis, technical dossiers.
S = SOPs, Safety practices, sanitation, storage, self-inspection,
standardization, supplier qualification, specifications and standard test
procedures and site master file.

20. STANDARD OPERATIONG PROCEDURES (SOP)
Atypical Pharmaceutical Industry has an average of 1200-1300SOPs.
A Parenteral Drug Association (PDA) survey found that atypical
pharmaceutical company must manage an average of 1250SOPs.
A Standard Operating Procedure (SOP) is a set of written instructions that
document a routine or repetitive activity which is followed by employees in
an organization.
The development and use of SOPs are an integral part of a successful
quality system.
It provides information to perform a job properly, and consistently in order
to achieve pre-determined specification and quality end-result.

21. The four suggested operational tiers of ISO 9001 : 2000 DOCUMENTATION :
Tier ISO 9001 Category Content Description Deals with...
I Quality manual
Corporate
Divisional
Departmental
A time-independent
document describing
the organization's
policies written in
conformance with the
Standard.
Scope of QMS
Details of exclusions
Documentation of
quality policy
Documentation of
quality objectives
Description of
organization
Identification of
processes
Description of
processes interactions
Inclusion or reference
of procedures
The organization's response to each
SHALL
The "rules of the house"—the
methods used to ensure compliance
Definition of responsibility

22. The four suggested operational tiers of ISO 9001 : 2000 DOCUMENTATION :
II Process documents and
high-level procedures
SOPs
Departmental
operating procedures
Business plans
Quality plans
Time-dependent
documents that
describe either the
overall processes of the
organization or a
combination of process
and high-level
procedures
Enterprise processes
Six mandatory
procedures
Documents needed to
ensure the effective
planning, operation,
and control of the
processes
Employee handbook
Purpose—what, when,
where, who, and why
at a high level
Flow of information
from area to area,
department to
department, building
to building

23. The four suggested operational tiers of ISO 9001 : 2000 DOCUMENTATION :
III Lower-level
procedural
documents
Wall reference
charts
Instructional
computer screens
Work instructions
Directions
Time-dependent,
detailed step-by-
step work
instructions on how
to complete a task
(e.g., at the
operator or bench
level)—sometimes
integrated into tier
II documents
Purchasing work
instructions
Manufacturing work
instructions
Training syllabus
How one does the
job—tells the
reader in a step-by-
step fashion
Provision of the
necessary data to
perform the tasks

24. The four suggested operational tiers of ISO 9001 : 2000 DOCUMENTATION :
IV Unfilled-in forms,
graphics, or spec sheets
Templates
Blueprints
Schematics
Specifications
Drawings
Generally time-
independent
documents that specify
the data requirements
called out in the various
documents and/or
specific data sources, or
graphically indicate
requirements or state
specifications
Many of the forms are
used as records once
they are filled in and
filed, although specific
records are required at
all levels
Complementary
documents to support
work instructions
The forms used to
demonstrate that a
procedure requiring
either data taking or
data input was done
Drawings and/or
specifications used in
manufacturing or
troubleshooting
The templates required
to measure and
fabricate

25. BENEFITS OF SOP
Toprovide people with all the safety, health, environmental and operational information
necessary to perform ajobproperly.
Toensure that production operations are performed consistently to maintain quality control of
processes
andproducts.
Toensure that processes continue uninterrupted and arecompleted on aprescribed schedule.
Toensure that no failures occur in manufacturing and other processes that would harm anyone in
the surrounding community
Toensure that approved procedures arefollowed in compliancewith company and government
regulations.
Toserve asatraining document for teaching usersabout the process for which the SOPwaswritten
Toserve asachecklist for co-workers who observe job performance to reinforce proper
performance.
Toserve asachecklist forauditors.
Toserve asanhistorical record of the how, why and when of steps in an existing process so there is
afactual basisfor revisingthose steps when aprocess or equipment arechanged.

26. SOP PROCESS
Preparation
Review and
Approval
Frequency of
Revisionsand
Reviews
Checklists Document Control
Document
Trackingand
Archival

27. HOW TO WRITE ?
OBJECTIVE:
TolaydownprocedureforthepreparationofStandardOperatingProcedures.
SCOPE:
ThisprocedureisapplicabletoalltheSOP’sthroughouttheorganization.
RESPONSIBILITY:
PersonPerforming:RespectiveHOD’sofconcerningdepartments
PersonMonitoring:QAofficer/HODQA
PROCEDURE:
AllSOP’sshallbecomputertypedusingTimesNewRomanfont.

28. HOW TO WRITE ?
Format of SOPshall be asper AnnexureSOP/QA/002/1.EachSOPhas:
I) Header,
II)Signature blockand
III)Body
Header: Present on all the pagesof SOPand includes
CompanyLogo,Name, address& ConcernedDept.:CompanyLogo,CHARAKPharma
Limited, Wag Holi-Pune & Nameof ConcernedDepartment.

29. HOW TO WRITE ?
DocumentType:Standard Operating Procedure (In capital bold letters of font
size14)
Ref.No.:It islike SOP/DC/YYY-ZWhere DCdepicts the department codeasbelow:
PE:PersonnelDepartment PD:Production Department
MT:Maintenance Department QA:Quality Assurance
Department QC:Quality Control Department ST:Store
Department
PU:PurchaseDepartment
YYYisthe sequentialnumber starting from 001for eachdepartment.
And Zisthe revision status,starting from 0 for the original version and 1for the next
version and soon. (In capital letters of font size12).

30. HOW TO WRITE ?
Supersedes:It isthe Ref.No.of the earlier version. (In capital letters of font size12).
Effective Date: It is the date from which the SOPshall be put in use. Thedate format has
to be DD/MM/YYYY,where DDindicates the date, MM indicates the month & YYYY
indicates the year(e.g.01/11/2007).Date shall be written with blue indelible ink pen.
Review Date: It is the Month & Yearduring which the SOPshall be revised e.g.
21/2013, written with blue indelible ink pen. It shall be maximum 2yearsfrom the
effective date.
PageNo.:It islike XOFY.WhereXisthe individual pagenumber and Yisthe total number of
pages.(In capital letters of font size12)

31. HOW TO WRITE ?
Title: It shall be clearand descriptive.(In bold capital letters of font size12).
SignatureBlock:It shall be below the header and only on the first pageof the SOP
.
(Titlesin the rows & columns shall be in bold letters & other text in normal letters of font
size
12.Nameand designation shall be typed. And signature and date shall be put in blue
indelible ink pen)
Preparedby:Signature with date, name and designation of the personfrom user
department
who hasdrafted the SOP
.
Verified by:Signature with date, name and designation of the HODor the personfrom
user department who hasverified the draft of the SOP
.
Authorized by:Signature with date, name and designation of the personauthorizing
SOP
, DGMQAor HODQA.

32. MASTER FORMULA RECORD
Master formula record (MFR) is a master document for any
pharmaceutical product.
It contains all information about the manufacturing process for the
product.
MFR is prepared by the research and development team of the
company and all other documents like BMR and BPR are prepared using
MFRby the manufacturing units.

33. PREPARATION OF MASTER FORMULA RECORD
A MFR should have following parts :
1. PRODUCT DETAILS : first of all on the first page following details about the
product are added.
NAME, LOGO and address of the manufacturing company
Dosage form name
Brand name, Generic name
Product code
Label claim of all ingredients
Product description
Batch size
Pack size and packing style
Shelf life, Storage conditions
MFR number and date
Supersede MFR number and date
Effective batch number
Authorization by the production and quality assurance head

34. PREPARATION OF MASTER FORMULA RECORD
2. Flow chart : steps of the manufacturing process to be monitored.
Flowchart of the material movement from dispensing to the final product
to stores.
3. Equipment : create a list of all required equipment and machines
required in the manufacturing process with their capacity.
4. Special instructions : write down the precautions special instructions to
follow during the product manufacturing and packing and these should also
be added in the batch manufacturing formula. Batch manufacturing
formula should include the following.
NAME OF INGREDIENTS WITH TEST REFERENCE (AS IP, BP, USP etc)
QUANTITY TO BE ADDED
OVERAGES TO BE ADDED(%)

35. PREPARATION OF MASTER FORMULA RECORD
5. CALCUTIONS :include the calculation steps of all active materials to get the
100% of the active material. The calculation shall be done using water content or
LOD to get 100% potency.
6. MANUFACTURING PROCESS : write all steps in all stages of the manufacturing
process. All process steps like shifting, milling, mixing, lubricating, granulation,
compression and coating should be written in detail including the process time
and yield. Include atmospheric conditions as temperature, humidity and storage
conditions for every step.
7. PACKING PROCESS : list of all packing materials with their quantity is written.
Line clearance, reconciliation of prined and unprinted packing materials should
be included in details.
8. YIELD : include the theoretical, actual yield and acceptance limit of the batch.

36. QUALITY AUDIT PLAN AND REPORTS
Conducting internal audits (self inspections) and external audits of
suppliers and outsourcing operations are key elements of a good quality
system.
One aspect of a quality system that is identified in the recently released
International Conference on Harmonization (ICH) Q10, “Pharmaceutical
Quality System”, and in other quality system standards such as ISO 9001, is
that of conducting audits as a means of evaluating compliance with the
objectives of the quality system.
Implementation of the quality management system model defined in
ICH Q10 should result in achievement of the three main objectives stated
in ICH Q10: Achieve product realization, establish and maintain a state of
control, and facilitate continualimprovement.

37. DOCUMENTATION AND COMMUNICATION
The audit results should be documented and communicated to
management.
The method of documentation and communication including the security
and confidentiality of the audit reports should be defined in the
procedure.
It is important to remember that those responsible for the audited
operation should always receive a copy of the report, including outsourcing
management and supplier management.
Such reports should clearly describe the audit team observations including
specific examples when possible.
If commitments have been made to implement corrective actions, such
commitments should be included in the report.
Security of audit reports should be strictly enforced and distribution of the
report should be limited.
When providing audit reports to external sources such as outsourcing
companies or suppliers, a subset of the internal report may be provided as
long as the observations are included

38. SPECIFICATION AND TEST PROCEDURES
A specification is defined as a list of tests, references to
analytical procedures, and appropriate acceptance criteria,
which are numerical limits, ranges, or other criteria for the
tests described.
It establishes the set of criteria to which a drug substance or
drug product should conform to be considered acceptable for
its intended use.
"Conformance to specifications" means that the drug
substance and / or drug product, when tested according to
the listed analytical procedures, will meet the listed
acceptance criteria.
Specifications are critical quality standards that are proposed
and justified by the manufacturer and approved by regulatory
authorities asconditions of approval.

39. PROTOCOLS AND REPORTS
A protocol is a written statement to conduct the process along with
the procedure, test method, equipment handling, specifications,
acceptance criteria, report andapproval.
The report summarizes all results, gives recommendations for fixing
errors and/or improving the overall quality of the speech corpus and
gives an executive summary.

40. DISTRIBUTION RECORDS
Distribution forms an important activity of the integrated supply chain
management of pharmaceutical products.
Various persons and entities are often responsible for the handling storage
and distribution of suchproducts.
The guidelines are intended to apply to all steps in the entire
distribution/supply chain
Permanent information, written or electronic, should exist for each stored
product indicating recommended storage conditions, any precautions to be
observed and retest dates.
Pharmacopoeia requirements and current national
regulations concerning labels and containers should be respected at
all times.
Procedures should be in place for temperature
mapping, security services at the warehouse, destruction of unsaleable
stocks and on retention of the records.

41. THANK YOU
adithyak713@gmail.com
7204282201