|
|
|
|
|
|
Project Planning & Project Management Document Templates (description below)
|
|
Analytical Methods Transfer:
Points to Consider |
| |
|
|
 |
This document
contains two aspects of analytical methods - transfer and validation guidelines
- along with a tabular summary of validation endpoints. The first part of
the document gives an overview of analytical method transfers and some key
considerations, which is helpful to provide consistency. The second
section is an overview of method validation requirements proposed by the USP,
FDA, and ICH, with the caveat that the method's use and stage of IND development
will dictate the level of validation. The final portion of the document
contains two summary tables (API and drug product) that detail the method,
method number and version, validation category, specification, and a brief
description of the validation/comments. This provides a great snapshot of
what testing is being performed for a program and what levels of validation have
been accomplished.
|
| Back to Top |
|
|
|
Analytical Test Method Descriptions |
| |
|
 |
Need to know the
difference of a DNA DOT-BLOT from a RT-PCR from a Northern Blot? This
could help - a tabular summary of different analytical methods with an overview
of the method of detection, uses, limitations, and other points to consider.
It's an excellent start to build from with respect to explaining the myriad of
tests and what they are assessing, especially for some cutting edge
immunological methods. The tabular summary allows for easy editing or
insertion of new data.
|
| Back to Top |
|
|
|
Common Technical Document (CTD):
Overall Table of Contents |
| |
|
 |
This
Word file is a detailed CTD table
of contents with
automatic leader tab in place and volume and page numbering set up.
This document makes it easier for setting up the detailed sub-sections of the CTD. Numbering within the tables is automatic so if you move sections
around slightly, they should be self-correcting. |
| Back to Top |
|
|
|
CTD Project Planning Table |
| |
|
 |
This Word file contains a
landscape formatted CTD table of contents (TOC) with detailed sub-sections and
areas for project assignment and tracking.
|
| Back to Top |
|
|
|
Team Biologics Audit Checklist |
| |
|
 |
This audit checklist (table
format) was created from the FDA Compliance Policy Guide (CPG 7341.001) and is
very flexible for both third-party audits as well as internal audits. Some
questions have been added to expand particular areas of compliance such as OOS
investigations and change control. The table format allows extensive
commentary on specific areas without complicated word processing.
|
| Back to Top |
|
|
|
European Union (EU) Audit Checklist |
| |
|
 |
This audit checklist (table format) was created from the Rules and
Guidance for Pharmaceutical Manufacturers and Distributors (2007)
that includes detailed audit checklists for all the key areas.
Since it's a Word file, you can modify as needed to fit particular
types of audits. Like the Team Biologics audit checklist, the
table format allows extensive commentary on specific areas without
complicated word processing.
|
| Back to Top |
|
|
|
Pre-IND Meeting Background
Information Packet |
| |
|
|
 |
This document was created based on refinements over the years.
Since the organization is already built in, it allows quick cut and
paste of large sections of text or data from other documents.
A note of advice: please do not submit your request for a
pre-IND meeting until you have completed a near final draft of
the background information packet and questions. The reason
for this is that some firms may send in the request missing some key
questions or insufficient data to make their case. By having
the background information packet nearly completed, you can complete
the questions for the meeting request with some confidence that
there is great consistency between the two documents. Note
that the same logic applies to End-of-Phase II (EOPII) meeting
requests or pre-NDA meeting requests. |
| Back to Top |
|
| |
IND Planning Table |
| |
|
 |
This landscape Word document is useful for daily or weekly tracking
of key items for the IND. It's a useful attachment to send to
team members letting them know specifics about what's outstanding.
|
| Back to Top |
|
|
|
Simplified IMPD Quality (Module 3)
Section |
| |
|
 |
This document was created based on a project that used an
investigational product for comparison to a commercially approved
product in the EU. Thus, simplified IMP could be employ for
clinical trials in the EU.
|
| Back to Top |
|
|
|
NDA Project Planning Table
(in CTD format) |
| |
|
 |
This document was created based on a 505(b)(2) application for a
solid oral dosage form compared to a reference listed drug with a
slightly different formulation. Thus, a number of non-clinical
and efficacy studies were not necessary, given the demonstrated
bioequivalence of the two formulations and identical clinical
indications. This landscape formatted document can be easily
modified to accommodate a full NDA or slightly revised to include
the data needed for a BLA. As with the IND planning table
above, this is an invaluable tool for easy tracking and project
management of the application. A trick I use is to keep a
running chronology within each major section that identifies when
significant documents are due or were received. This provides
an at-a-glance view for anyone new to the project.
|
| Back to Top |
|
|
|
|
|
|
|
|
|
