3. INTRODUCTION
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Documentation is the cornerstone of any company’s quality management
system and is an essential GMP requirement.
anyone dealing with GMPdocuments and documentation systems
understand the regulatory requirements and adopts best practice.
It defines a system of information and control so that risks inherent in
misinterpretation and/or error in oral communication are minimized.
5. OBJECTIVESOFDOCUMENTS
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Todefine the specifications and procedures for all materials and method of
manufacture andcontrol.
Toensure that all personal concern with manufacture know what todo and
when to doit.
Toensure that authorized persons have all the information necessary to
decide whether or not to release abatch of adrug for sale.
T
o ensure the existence of documented evidence, trace ability, and to
provide records that will permit investigation.
It ensures the availability of the data needed for validation, review and
statistical analysis.
6. SCOPE
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Good documentation encompasses practically all the aspect of
pharmaceutical production :
Building and premises: installation, validation , cleaning and maintenance
Personnel : Training, hygieneetc
Equipment : installation , calibration , validation , maintenance , cleaning
Materials: specification, testing,ware-housing, use, rejection/disposal.
Processing: individual steps in the process of manufacturing including
controls
Finished goods: specifications, testing, storage, distribution, and
rejection/disposal.
9. Typesof documents
Quality manual
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Policies
Standard
operating
procedures
(SOPs)
Batch records
Testmethods
Specifications
Logbooks
10. CHARACTERISTICOFDOCUMENT
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For effective use of documents, they should be designed and prepared with
utmost care. Eachdocumentshall:
(i) Have aclear title.
(ii) Have an identification number.
(iii) Beapproved by authorizedperson.
(iv) Have the date ofissue
(v) Have adue date of revision.
(vi) List to whom it has been issued.
11. “Where the documents carry instructions”
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(i) The instructions shall be precise and not ambiguous.
(ii) They shall be for each individual step and not combined.
E.g. Weigh the materials
(iii)Instructions shall be in imperative mood.
12. “Where entry of anydata isexpected”
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(i) Sufficient spaceshall be provided for making the entry.
(ii) All entries shall be in ink.
(iii) All entries shall be clear and legible.
(iv) Person making the entries shall confirm the entry by initialing/signing the
same.
13. DOCUMENTATIONREVIEW
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Documentation system should provide for aperiodic review, and revision, if
necessary, of any document, or part thereof.
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.
14. ELECTRONICDATA
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If documentation is through electronic data processing system
(computerized system) there shall be adequate, reliable systems in place:
1.Tocheck and ensure correctness of data.
2. Torecord changes (addition/deletion)
3.That meets other regulation requirement, if any
15. “DOCUMENTS”MODEL
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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= Userrequirement specifications, utilities like water systems, HVAC,AHU etc.
M= Man, materials, machines, methods, maintenance, manufacturing operations and controls, monitoring,
master formula, manuals (quality, safety and environment), 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,
specifications and standard test procedures and site master file
supplier qualification,
16. STANDARDOPERATINGPROCEDURES(SOP’S)
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Atypical Pharmaceutical Industry has an average of 1200-1300SOPs.
A Parenteral Drug Association (PDA) survey found that a typical
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.
17. BENEFITSOFSOP
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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
and products.
Toensure that processes continue uninterrupted and are completed on a prescribed schedule.
Toensure that no failures occur in manufacturing and other processes that would harm anyone in the
surrounding community
Toensure that approved procedures are followed in compliance with company and government regulations.
Toserve asa training document for teaching users about the process for which the SOPwas written
Toserve asachecklist for co-workers who observe job performance to reinforce proper performance.
Toserve asachecklist for auditors.
Toserve asan historical record of the how, why and when of steps in an existing process so there is a factual
basis for revising those steps when a process or equipment are changed.
19. “How to write?”
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OBJECTIVE:
Tolay down procedure for the preparation of Standard Operating Procedures.
SCOPE:
This procedure is applicable to all the SOP’sthroughout the organization.
RESPONSIBILITY:
Person Performing: Respective HOD’s ofconcerning departments
Person Monitoring: QAofficer/HODQA
PROCEDURE:
All SOP’sshall be computer typed using TimesNew Roman font.
20. “How towrite?”
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Format of SOPshall be asper AnnexureSOP/QA/002/1.EachSOPhas:
I) Header,
II) Signature block and
III) Body
Header: Present on all the pages of SOPand includes
Company Logo, Name, address & Concerned Dept.: Company Logo, CHARAKPharma
Limited, Wagholi-Pune & Name of Concerned Department.
21. “How towrite?”
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Document Type:Standard Operating Procedure (In capital bold letters of font size 14)
Ref. No.: It is like SOP/DC/YYY-ZWhere DCdepicts the department code asbelow:
PE:Personnel Department PD:Production Department
MT: Maintenance Department QA: Quality Assurance Department
QC:Quality Control Department ST
:Store Department
PU: Purchase Department
YYYis the sequential number starting from 001for each department.
And Zis the revision status, starting from 0 for the original version and 1for the next version
and so on. (In capital letters of font size 12).
22. “How towrite?”
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Supersedes: It is the Ref. No. of the earlier version. (In capital letters of font size 12).
Effective Date: It is the date from which the SOPshall be put in use. The date format has to
be DD/MM/YYYY, where DDindicates the date, MM indicates the month & YYYYindicates the
year (e.g. 01/11/2007).Date shall be written with blue indelible ink pen.
Review Date: It is the Month & Year during which the SOPshall be revised e.g. 21/2013,
written with blue indelible ink pen. It shall be maximum 2years from the effective date.
PageNo.: It is like XOFY
.Where Xis the individual page number and Yis the total number of
pages. (In capital letters of font size 12)
23. “How towrite?”
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Title: It shall be clear and descriptive. (In bold capital letters of font size 12).
Signature Block: It shall be below the header and only on the first page of the SOP
.
(Titles in the rows & columns shall be in bold letters & other text in normal letters of font size
12.Name and designation shall be typed.And signature and date shall be put in blue indelible
ink pen)
Prepared by: Signature with date, name and designation of the person from user department
who has drafted the SOP
.
Verified by: Signature with date, name and designation of the HODor the person from user
department who has verified the draft of the SOP
.
Authorized by: Signature with date, name and designation of the person authorizing SOP
,
DGMQAor HODQA.
24. “How towrite?”
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Body: It shall contain the subject matter, which is written in the following Manner.
(Subtitles in capital bold letters and text matter in normal letters of font size 12).
OBJECTIVE:It shall define the purpose of the SOP
.
SCOPE:It shall define the area of application.
RESPONSIBILITY:It shall specify the person responsible for carrying out and monitoring the
activity asper theSOP
.
25. “How towrite?”
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PROCEDURE: It shall give all steps required by the process in a proper sequence and
instructions to be followed while carrying out the activity so asto achieve the desired goals.
Procedure shall be:
a) Logically layout.
b) Written in the imperative (authoritative) tense.
c) User friendly.
d) Simple to understand and in plain unambiguous English.
e) Tothe point with no unnecessary information.
f) In standardizedterminology.
26. “How towrite?”
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ABBREVIATION:This shall include list of abbreviations used and their meaning.
ANNEXURE:This shall include list of annexure attached.
REFERENCE:This shall include list of referencedocuments.
ABBREVIATION:
HOD: Head of the Department SOP: Standard Operating Procedure.
QA: Quality Assurance DGM: Deputy General Manager
ANNEXURE:
Annexure – SOP/QA/002/1 -‘Standard Operating Procedure’Form.
REFERENCE:
SOPissuance logbook
Standard SOPformat.
28. MASTERFORMULARECORD
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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 MFR by the
manufacturing units.
31. BATCHFORMULARECORD
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A batch manufacturing record is a document designed to provide a
complete record of the manufacturing history of abatch of product.
The USFood and Drug administration defines a batch as “a specific quantity
of a drug or other material that is intended to have uniform character and
quality, within specified limits, and is produced according to a single
manufacturing order during the same cycle of manufacture”.
32. PREPARATIONOFBMR
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They normally contain information that relates to the following aspects of the manufacture of a batch of product:
Dates of start and finish of manufacture.
Lists all materials used and amounts ofeach used.
Lists of packaging materialsused.
Details of the steps completed in the manufacturing process and times of completion.
Initials of the person responsible at every stage.
Details and results of allin-process checks.
Reference to any equipmentused.
Batch yield andreconciliation.
Any deviations.
Quality Control information.
33. Documentation and communication
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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 acopy 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 shouldbe
included in thereport.
Security of audit reports should be strictly enforced and distribution of the report should be
limited.
34. SPECIFICATION AND TEST PROCEDURES
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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 listedacceptance criteria.
Specifications are critical quality standards that are proposed and justified
by the manufacturer and approved by regulatory authorities as conditions of
approval.
35. PROTOCOLS AND REPORTS
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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.
36. DISTRIBUTION RECORDS
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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.
Pharmacopoeial 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
37. ELECTRONIC DATA
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Electronic data can stand for
data in general that is exchanged via electronic communication lines
digital data inparticular
Data (computing), i.e. computer -processable data asopposed to executable code
Note that electronic information includes everything such as emails, adverse event reports,
complaints, batch records, quality control records -everything that is stored electronically.
Several technologies are being used currently in pharmaceutical industry to manage theirhuge
volumes of data generated on daily basis.
