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38 views17 pages

Documentation - 1

Uploaded by

Lovely Jimson
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© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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IV.

Documentation in
Pharmaceutical Industry

Dr Mrs Sugandha V Mulgund


• Documentation in pharmaceutical industry:
• Three tier documentation, Policy, Procedures and Work instructions, and
records (Formats)
• Basic principles- How to maintain, retention and retrieval etc. Standard
operating procedures (How to write), Master Batch Record, Batch
Manufacturing Record
• Quality audit plan and reports. Specification and test procedures, Protocols
and reports.
• Distribution records. Electronic data handling.
• Concepts of controlled and uncontrolled documents.
• Submission documents for regulators DMFs, as Common Technical Document
and Electronic Common Technical Documentation (CTD, eCTD).
• Concept of regulated and non regulated markets.
Standard Operating Procedures:

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.
SOPs should allow for the continual improvement of
standards of service.
BENEFITS OF SOP
• To ensure that processes continue uninterrupted and are completed on a
Described schedule. Ensure against process shut-downs caused by
equipment failure or other facility damage.
• To ensure that no failures occur in manufacturing and other processes that
would harm anyone in the surrounding community.
• To ensure that approved procedures are followed in compliance with
company and Government regulations. Well-written SOPs help ensure that
government regulations are satisfied.
• To serve as a training document for teaching users about the process for
which the SOP was written. Thorough SOPs are used as the basis for
providing standardized Training for employees who are new to a particular
job and for those who need retraining
• To serve as a checklist for co-workers who observe job performance to
reinforce proper performance. The process of actively caring about fellow
workers involves one worker coaching another in all aspects of proper job
performance.

• To serve as a checklist for auditors. Auditing job performance is a process


similar to Observation mentioned in the previous item. SOPs should serve
as a strong basis when detailed audit checklists are developed.

• As people move from job to job within and between companies, unwritten
knowledge and skills disappear from the workplace. Properly maintained
written SOPs can chronicle the best knowledge that can serve new workers
when older ones move on
To serve as an explanation of steps in a process so they can be reviewed in
accident investigations. Although accidents are unfortunate, view them as
opportunities to learn how to improve conditions. A good SOP gives you a
basis from which to being investigating accidents
SOP REQUIREMENTS
Prepare apex documents like Quality Policy, Quality Manual, Site Master File,
Validation Master Plan, etc. to describe the quality commitments of the
management
Define the roles and responsibilities of all personnel working in the
organization
Prepare policy for periodic review of documents. Ensure that the current
industrial practices and Pharmacopoeial requirements are fulfilled by the
current versions of documents
SOP for document (SOPS, MPCR, BPCR, validation/qualification protocols,
formats)preparation, review, approval, training, distribution, control, and its
retention
Procedure for maintaining revision history
Management, control, and retention of superseded or obsolete documents
Document archival and retrieval procedure
Handling, archival, retrieval, and retention of electronic records/documents
Procedure for control of electronic signatures
Equipment cleaning and sanitation procedure
Issuance and control of equipment logs
Document describing measures taken for avoidance of cross contamination and it's
training records
Cleaning validation master plan
Procedure for batch-to-batch and product-to-product cleaning and its verification to
ensure removal of residue of previous batch/product
Records for incoming raw materials and packaging materials
 SOP for preparation of process validation protocol and reports
 SOP for preparation of master production control records
 SOP for preparation of batch manufacturing and control records
 SOP for allocation of batch number
 Calibration master plan and calibration reports
 Batch release procedures
 SOP for preparation and control of QC data sheet
 SOP for allocation of analytical control number
 Procedure for review of analytical data
 SOP for change control, revision of any process or documents, or
upgradation of facility or equipment should be routed through impact
assessment and change control procedure
FORMAT OF TECHNICAL SOP
• In general, technical SOPS will consist of five elements:
• 1. Title Page.
• 2. Table of Contents
• 3. Procedures - The following are topics that may be appropriate for inclusion
in technical SOPS. Not all will apply to every procedure or work process being
detailed.
• a. Scope and Applicability (describing the purpose of the process or procedure
and any organization or regulatory requirements, as well as any limits to the
use of the procedure),
• b. Summary of Method (briefly summarizing the procedure)
• c. Definitions (identifying any acronyms, abbreviations, or specialized terms used),
Health & Safety Warnings (indicating operations that could result in personal injury
or loss of life and explaining what will happen if the procedure is not followed or is
followed incorrectly.
d. Cautions (indicating activities that could result in equipment damage,
degradation of sample, or possible invalidation of results; listed here and at
the critical steps in the procedure)
e. Interferences (describing any component of the process that may interfere
with the accuracy of the final product)
f. Personnel Qualifications/Responsibilities (denoting the minimal experience
the user should have to complete the task satisfactorily, and citing any
applicable requirements, like certification etc.
g. Equipment and Supplies (listing and specifying, where necessary, equipment, materials,
reagents, chemical standards, and biological specimens
h. Procedure (identifying all pertinent steps, in order, and the materials needed to
accomplish the procedure such as:
 Instrument or Method Calibration and Standardization
 Sample Collection
 Sample Handling and Preservation
 Sample Preparation and Analysis (such as extraction, digestion, analysis, identification,
and counting procedures)
 Troubleshooting
 Data Acquisition, Calculations & Data Reduction Requirements (such as listing any
mathematical steps to be followed)
 Computer Hardware & Software (used to store field sampling records, manipulate
analytical results, and/or report data)
 Data and Records Management (e.g., identifying any calculations to be performed,
forms to be used, reports to be written, and data and record storage information).
4 Quality Control and Quality Assurance Section –
QC activities are designed to allow self-verification of the quality and
consistency of the work.

Describe the preparation of appropriate QC procedures (self-checks, such as


calibrations, recounting, reidentification) and QC material (such as blanks,
replicates that are required to demonstrate successful performance of the
method.

Specific criteria for each should be included. Describe the frequency of


required calibration and QC checks and discuss the rationale for decisions.
Describe the limits/criteria for QC data/results and actions required when QC
data exceed QC limits or appear in the warning zone. Describe the procedures
for reporting QC data and results.
5 Reference Section - Documents or procedures that interface with the SOP
should be fully referenced (including version), such as related SOPS,
published literature, or methods manuals. Citations cannot substitute for the
description of the method being followed in the organization. Attach any that
are not readily available.
DISTRIBUTION RECORD
• Maintenance of records of finished product is essential to facilitate complete
recall of Batch if necessary. Distribution records are written data related to
distribution of Drug products from the manufacturer to the distributors. The
complete data regarding all batches of drug products should be maintained.
• It shall include the following:-
•  A procedure whereby the oldest approved stock of a drug product is
distributed first. Deviation from this requirement is permitted if such
deviation is temporary and appropriate.
•  A system by which the distribution of each lot of drug product can be
readily Determined to facilitate its recall if necessary
•  The manufacturer must maintain records of all distribution transactions
involving in Process or finished goods
 A variety of distribution recording system must be utilized
 Computerized tracking systems are most common but paper systems Such
as Recording the lot or control number on the retained copies of the
shipping invoices or Recording the dates on which each lot commenced
distribution also can be used.

 Particulars in Distribution records


 Name
 Dosage Form and Strength of the Consignment (or delivery)
 The quantity of a pharmaceutical(s), made by one manufacturer and
supplied at one Time in response to a particular request or order. A
consignment may comprise or More packages or containers and may
include material belonging to more than Batch.
 Name And Address of Consignee
 Date And Quantity Shipped
 Name, Address And Number Of The Customer That The Product Is
Shipped To
 Delivery Order Delivered Date And Number
 Quantity
 Product Batch Number
 Expiry Date
 Date of dispatch
 Quantity of the products, i.e. Number of containers and quantity per
container
 Special Storage Requirement or Precautionary Measures to Handle the
Product.
 A unique number to allow identification of the delivery order

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