TECHNOLOGY TRANSFER PROTOCOL

By: AMMAR AHMAD

RAZI AHMAD
B. PHARM 4th Year
Faculty Of Pharmacy, JIT
 Technology Transfer Protocol

DEFENITION:-
Technology transfer “refers to the processes of
successful progress from drug discovery to product
development, clinical trials and ultimately full scale
commercialization.
 The transfer protocol should list the intended
sequential stages of the transfer. The protocol should
include:-

 Objective: It indicates the project involved in addition to the laboratories

involved in the technology transfer.
 Scope: It defines the methods that will be transferred and the methods which do
not require transfer.
 key personnel and their responsibilities;
 a parallel comparison of materials, methods and equipment;
 the transfer stages with documented evidence that each critical stage has been
satisfactorily accomplished before the next commences;
 identification of critical control points;
 experimental design and acceptance criteria for analytical methods;
 information on trial production batches, qualification batches and process
validation;
 change control for any process deviations encountered;
 assessment of end-product;
 arrangements for keeping retention samples of active ingredients,
intermediates and finished products, and information on reference substances
where applicable; and
 Conclusion, including signed-off approval by project manager.

Quality Risk Management (QRM):-

Quality risk management is defined as “ a systematic process for the
identification, assessment and control of risks to the quality of
pharmaceutical products across the product lifecycle
 Principles of Quality Risk Management:-

 The two primary principles of QRM are:

1-Evaluation of quality risk should depend on scientific knowledge and related to
the protection of the patient, and
2-The amount of effort, formality and documentation of the QRM process should
be proportionate to the amount of risk.

 Apart from these, the following principles are also a constituent of QRM
procedure:
1-When applied, processes employing QRM procedures should be dynamic,
repetitious, and open to change, and
2-The ability for continuous improvement should be included in the QRM
process.
 QRM Application in
Pharmaceuticals:-

 Training and Education.

 Responsibilities.
 QRM Application during Product Development .
 QRM Application during Validation and Qualification.
 QRM Application during Commercial Manufacturing.
 Development of Technology by R&D

This step involves the following:

 Design of Procedure and Selection of Excipients by R&D:
Based on the features of the innovator product, R&D designs procedures
and selects excipients.
 Identification of Specification and Quality by R&D: Whether
or not the product quality complies with the specifications of the
innovator product is evaluated by R&D by performing stability studies
for the innovator product and the product to be manufactured
 Transfer from R&D to Production
 Technology Transfer Dossier(TTD) is a document presented by R&D to product
development laboratory and includes the information (given below) related to the
formulation and drug product:
 Master Formula Card (MFC): It provides information on the product name,
generic name, strength, MFC number, page number, effec tive date, shelf-life, and
market.
 Master Packaging Card: It provides information regarding the type of
packaging, material used for packaging, stability profile of packaging, and
packaging shelf-life.
 Master Formula: It provides information regarding the formulation order
and manufacturing instructions, which in turn gives idea of process order,
environmental conditions required, and manufacturing instructions for dosage
form development.
 Specifications and Standard Test Procedure (STPs): These provide
information regarding the API and excipients profile, in -process parameters and
specifications, product release specification, and finished product details.
The technical expertise, site technology , and site abilities for the RU should be
considered. It should be recognized by the SU of any process robustness issues so
that proper plans could be made at the RU.
 Process:-
The SU should give information to the RU on present processing and testing,
including:
 An explanation of facility requirements and equipment,
 Data on starting materials, applicable MSDS , and storage needs for raw materials and
finished products,
 An explanation of manufacturing steps (description and process maps or flow charts, and
or master batch records), qualification of in processing hold times and situations,
order and procedure of raw material addition and bulk transfers within processing phases,
 An explanation of analytical methods,
 Recognition and verification of con trol strategy [e.g., recognition of important
performance aspects for particular dosage forms, recognition of process control points,
product quality aspects and qualification of important processing parameter ranges,
Statistical Process Control (SPC) charts],
 Design space, in circumstances where it has been described,
 Validation data, e.g., validation plans and reports,
 Annual product quality reviews,
 Stability information,
 An approved group of protocols and operation guidelines for manufacturing, and
 Environmental conditions or any particular obligation required for the facility or equipment
based on the nature of the product to be transferred.
 Packaging
 Data on packaging to be transferred from the SU to the RU contains
specifications for an appropriate container or closure system, and also
any important supplementary data on packaging, de sign, processing
or labelling requirements and tamper -proof and anti -counterfeiting
measures required for qualification of packaging components at the RU.
For QC testing of packaging components, specifications should be given
for drawings, artwork , and material (e.g., card, glass, or fiber board).
 Packaging is thought to be appropriate if it offers sufficient protection
( preventing drug degradation from environmental conditions), safety
(absence of unwanted substances released into the product),
compatibility (absence of interaction that may affect drug quality),
and performance (functionality concerning drug delivery).
 Cleaning
Cleaning processes and their verification are site-specific. For RU to state
its cleaning approach, the SU should give data on cleaning at the SU to
reduce cross-contamination because of residues from the earlier
manufacturing stages, operator exposure, and environmental impact, such
as:
 Information on solubility of active ingredients, excipients, and vehicles,
 Minimum therapeutic doses of active ingredients,
 Therapeutic category and toxicological assessment, and
 Current cleaning procedures.
The following additional data should be given:
 Cleaning validation reports (chemical and microbiological),
 Information on cleaning agents used, including their efficacy, evidence
that they do not interfere with analytical testing for residues of APIs and
remove residual cleaning agents, and
 Recovery studies to validate the sampling method.
Thank you