Documentation in Pharmaceutical Industry Part I

DOCUMENTATION IN
PHARMACEUTICAL INDUSTRY
Presented By…..
Mr. Tarif Hussian
M.Pharm. (DRA)
Guided By…..
Dr. (Mrs.) Sanju Nanda
Professor of Pharmaceutics

CONTENTS
 INTRODUCTION
 DOCUMENTATION
 PHARMACEUTICAL DOCUMENTS
 ALCOA & ALCOA+
 DRUG SUBSTANCE
 DRUG PRODUCT
 EXPLORATORY PRODUCT DEVELOPMENT BRIEF
(EPDB) FOR DRUG SUBSTANCE AND DRUG PRODUCT

INTRODUCTION
 A DOCUMENT is a piece of written, printed, or electronic
matter that provides information or evidence or that serves as
an official record.
 Documents should be designed, prepared, reviewed, and
distributed for use per established procedures.
 Good Documentation Practice (GDP or GDocP), a term
use in the pharmaceutical industry, is essential for the
integrity of data collection and reporting for supporting
development, registrations, commercialization, and life-cycle
management of pharmaceutical products.

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 & How to Complete
tasks
2. Evidence providing that the tasks have been completed as
they should be.

DOCUMENTATION should be as detail as possible. A list of some examples (but not limited
to) to be included in the document are:
 D = Design, Development, deviations, dossiers and Drug Master Files for regulated
markets, Distribution Records etc.
 O = Operational procedures/techniques/methods, Out of specifications (OOS), Out of trend
(OOT) etc.
 C = Cleaning, calibration, controls, complaints, Certificate of Analysis (CoA) ,containers
and closures, contamination and change control etc.
 U = User requirement specifications, utilities like water systems, HVAC, etc.
 M = Man, materials, machines, methods, maintenance, MANUFACTURING operations and
controls, monitoring, master formula, manuals (quality, safety and environment), medical
records, Master Formula Record etc.
 E = Engineering control and practices, Environment control, Equipment qualification
documents, Exploratory Product Development Brief (EPDB) for Drug substance and
Drug product etc.
 N = Non-routine activities, New products and substances etc.
 T = Technology transfer, training, testing, Trend analysis, Technical dossiers etc.
 S = SOPs, safety practices, sanitation, storage, self-inspection, standardization, supplier
qualification, specifications and standard test procedures and SITE MASTER FILE.

PHARMACEUTICAL DOCUMENTS
Good documentation were first described by US-FDA in the form of ALCOA –
A = Attributable (Records and data linked to the individual or system
performing the action.)
L = Legible (All data recorded must be legible (readable) and permanent)
C = Contemporaneous ( Record the result, measurement or data at the
time the work is performed. )
O = Original (Source information accessible and preserved in its original form)
A = Accurate (Data are correct, truthful, complete, valid and reliable.)
 NOTE - Proper verification of source documents to ensure data integrity,
validity, and subject safety among other aspects.

ALCOA+
Recently ALCOA has been updated to ALCOA+ which is widely been used
by the WHO and FDA.
 Complete - All data is available, nothing has been deleted and evidence
must be available in an audit trail.
 Consistent - Data is recorded chronologically with data and time evident
again in an audit trail.
 Enduring - Data is accessible for an extended period of time.
 Available - Data is accessible over the lifetime of the product.

DRUG SUBSTANCE
 DRUG SUBSTANCE is an active ingredient that is intended to furnish
pharmacological activity or other direct effect in the diagnosis, cure, mitigation,
treatment, or prevention of disease or to affect the structure or any function of
the human body, but does not include intermediates used in the synthesis of
such ingredient.
 Demonstration batch
 Certificate of analysis for each batch
manufactured (final API and reference
standards)
 BSE/TSE statements and GMP certificate
 Process development (including
manufacture of demonstration batch) report
 Process safety assessment report
 cGMP campaign report
 Master and executed batch records
 Analytical test procedures, methods validation
protocols and reports
 Reference standards and analytical markers
characterization report
 Forced degradation study report
 Specifications for API release
 ICH stability protocol, interim and final reports
 Biweekly updates on project progress
 Documentation suitable for IMPD submission

DRUG PRODUCT
 DRUG PRODUCT is a finished dosage form, e.g., tablet, capsule, or solution, that
contains a drug substance, generally, but not necessarily, in association with one or
more other ingredients.
 Clinical batches supply
 Certificate of analysis and statement of cGMP compliance (per batch manufactured)
 TSE statements for excipients
 Formulation development reports
 Executed batch records for DP manufacturing
 Analytical test procedures, methods validation protocols and reports
 Specifications for DP release
 ICH stability protocol, interim and final reports
 Biweekly updates on project progress
 Documentation suitable for IMPD submission

ExPDB DOCUMENTS
EXPLORATORY PRODUCT DEVELOPMENT BRIEF - Clarify
preclinical and clinical approaches, as well as chemistry,
manufacturing, and controls information, should be considered when
planning exploratory studies in humans, including studies of closely
related drugs or therapeutic biological products, under an
investigational new drug (IND) application.
Information on a clinical development plan .
 Chemistry, manufacturing, and controls information .
 Pharmacology and toxicology information .
 Previous human experience with the investigational candidate or
related compounds.
 Other.

 CLINICAL INFORMATION
Introductory statement and general investigational plan
Types of studies
CHEMISTRY, MANUFACTURING, AND CONTROLS INFORMATION
General information for the candidate product
Analytical characterization of candidate product
SAFETY PROGRAM DESIGNS
Clinical studies of pharmacokinetics or imaging
Clinical trials to study pharmacologically relevant doses
Clinical studies of MOAs related to efficacy
GLP COMPLIANCE
CONCLUSION

Documentation in Pharmaceutical Industry Part I

Documentation in Pharmaceutical Industry Part I

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Documentation in Pharmaceutical Industry Part I