| International Journal of Generic
Drugs
International
Journal Series
ISSN 0793-694X
Vol. 1 - Table of Contents
Number 01 - 08
ISSN 0793-694X
Table of Contents - Vol 1. Number 01
Development SOPs
The Stability SOPs & Stability Technology
Stability SOPs
Standard Operating Procedures (SOPs)
and Key SOP Summaries
Pharmaceutical
Standard Operating Procedures (SOPs)
Microbiological
Standard Operating Procedures (SOPs)
Analytical
Standard Operating Procedures (SOPs)
Stability
Setting-up a functional unit! - 77 Stability Do's
and Don'ts
TTDs
What to expect when transfering from research & development to production
I.A.G.I.M
How it Works & the benefits you
get !
Table of Contents - Vol 1. Number 02
COMMENT
Editorial Comment PAIs
Pre-approval Approvals - On PAI Technology.
Preparing for a successful in depth inspection
Pivotal to Validation
Using Simple Inventory Cards to track the active material
ANDA Capsules
Fleshing out OGD’s ageing 1991 Table of Contents - ANDA Checklists.
I.A.G.I.M
A unique Drug Development Association for Generic and
Innovative Drugs with a difference.
Pivotal Batch
Complete product disbursements of the manufactured and
packed units of the registration batch as the FDA like to see it.
Capsule Trails
Packaging the entire pivotal lot into the various marketing packs for
stability needs a clear trail - for FDA scrutiny.
submission batch - tabulating where the pivotal production material
actually went - down to the last dosage unit.
Pre-approval
Checklist On PAI Technology: From initial set up to
final audit activities of the integrated PAI Team.
Table of Contents - Vol 1. Number 03
Development
Developing the formula - an overview...
Development Documentation.
Materials
Active Ingredients their Source and Supply forever?
Manufacture
Scaling-up of Semi Solid Topical preparations on the production floor..
Analytical Aspects
Analytical Validation - a working validation protocol for HPLC systems...
Stability
Stability Reports - as the FDA Office of Generic Drugs Require...
Do's and don'ts in Stability Documentation.
Technical Transfer Documentation
Analytical TTD file - Content & Principles.
Part I of a III part series...
Regulatory
Sit and review the generic drug with the regulatory before you start...
SOPs & Checklists
OOS - Out-of Specifications in a Stability Study...
When to Stop a Stability Study on Time..
Table of Contents
- Vol 1. Number 04
Development
Cleaning validation.
Developing the protocol.
Materials
Purified Water USP - An ingredient for semi solid development lots.
Manufacture
Side-by-side comparisons.
Pivotal to Validation.
Analytical
Analytical Validation - Part II.
Stability
Out of Specifications Procedures for Repeat Testing
- Part II.
Technical Transfer
The TTD - Part II of a III part series.
Regulatory
US Drug Enforcement Act - made simple.
SOPs & Checklists
key SOPs and Checklists you should have.
Table of Contents - Vol 1. Number 05
Article 1
The Thirteen Commandments - on drug development rules from pre-formulation
to agency inspection.
Article 2
Review on ANDA Submission as an eight part series. Emphasis on the value
of hardness qualification and unit dose sampling.
Article 3
Explanation on how the OGD ANDA is presented in the Journal the Issues.
Article 4
ANDA - Section 1 of the file preparation providing a detailed table
of contents for a extended release tablet.
Article 6
Section 2 of the file preparation establishing the basis for the ANDA
submission.
Article 7
Section 3 of the file preparation evaluating the patent certification
and exclusivity data with supporting data.
Article 8
Section 4 of the file preparation. Comparing the Generic to the Reference
Listed Drug (RLD).
Article 9
Section 5 of the file preparation. A full labeling profile of what is
required.
Article 10
Agency Corner - FDA'er Paul Motise's Notebook on current GMP issues.
Article 11
Blend Analysis - Unit dose sampling - handling the 'ins-and-outs' of
pivotal batch sampling.
Article 12
Pivotal Batch Sampling requirements. Representative sampling and recording
procedures as expected by the Office of Generic Drugs.
Article 13
Sampling Records from granulation to film coating. The need for proof
of sampling.
Article 14
Blend Analysis - Do's and Don'ts on how to sample consistently.
Article 15
NEXT ISSUE HIGHLIGHTS.
Table of Contents
- Vol 1. Number 06
Article 1
Review on ANDA Submission as an eight part series. Emphasis on the value
of hardness qualification and unit dose sampling.
Article 2
'13 Commandments' - Rules on Drug Development from pre-formulation to
agency inspection.
Article 3
Explanation on ANDA presentation in the Journal Issues.
Article 4
ANDA - details of this issue and all related Journal issues.
Article 5
Bioequivalence - Generic vs. Reference Listed Drug -
evaluating the generic drug against the RLD from development to submission.
Article 6
An FDA outline model of a biostudy protocol structure.
Article
7
ANDA Section 6 The structure and contents of the Bioequivalent section
of an ANDA.
Article 8
ANDA Section 7 Composition for the proposed formula for submission with
side-by-side comparison tables.
Article 9
Auditing the pivotal batch - a self inspection of the
pivotal documentation before submission to the FDA Office of Generic
Drugs.
Article 10
Pivotal batch checklist for in-house evaluation prior to submission.
Article 11
Qualifying Tablet Hardness - A critical manufacturing parameter, required
by the Agency for product approval
Article 12
Qualifying Tablet Hardness - A working hands-on Protocol
Article 13
Agency Corner FDA Note Book - Fda'er Paul Motise.
Table of Contents
- Vol 1.
Number 07
COMMENT
Part Three of an Eight Part Series on a Controlled Release model
preparation of a Tablet presentation for a US Abbreviated New Drug Application
PREDICTING 1998+
How the FDA-ICH linked guidelines may impact on drug development in
the new two years (1998 to 1999).
DEVELOPING THE FORMULA
ANDA Formula development of a new Generic covering all stages from A
(Actives) to V (Process validation).
PRODUCT DEVELOPMENT
Twenty one sequential steps needed to be followed for product development
with flowchart 07-12.
ANDA Section VIII
ANDA Raw Material and their controls. What to expect in 1998?
ANDA Section IX
R&D and Manufacturing facilities description emphasising foreign
facilities
ANDA Section X
Outside Firms and Manufacturing Contract Facilities. Documentation that
is needed.
PROCESS VALIDATION
Development and Process Validation (D&P) - the Big Picture
of current and the nearby future impact of FDA's Q6A guideline.
ANALYTICAL
Separating Ruggedness & Robustness in Analytical Validation.
Table of Contents - Vol 1. Number 08
COMMENT
Part FOUR of an Eight Part Series on Controlled Release Oral Tabs. A
detailed model application of a tablet presentation for a US Abbreviated
New Drug Application
R&D STRATEGY
A R&D Strategy detailing a well defined research and development
management program is geared to become the make or break tool for the
drug development industry.
ANDA Series
Explanation on how the overall OGD ANDA series is presented in the International
Journal Issues.
ANDA Section XI
Describing the Manufacturing Process in terms of the underlying parameters
Manufacturing Flow Chart
Blank Master Records
Blank Packaging Records
Formula Comparisons
Equipment Comparisons
Describing the Packaging Operation
Reprocessing Statements
Semi-Actives
Validating the Semi-active Formula Ingredients during process optimization
by challenge the rationale of each preservative or anti-oxidant in the
system and then optimising its formula concentration.
Qualifying the Right Amount of Antioxidant
Necessary
Qualifying the antioxidant concentration in a solid oral dosage form
at the process optimization stage of devvelopment.
Drugs Off-Patent
R&D Pipeline Strategy for the coming millennium
highlighting Major Drugs Off-Patent to 2003 with 70 expired Drugs with
No Approved ANDA Yet and the Global Sales figures for past three years.
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