Manufacturing Lec (Midterm)
Distribution • The intermediary that ships products from
• An important activity in the integrated
supply-chain management of pharmaceutical
products.
• The entire system of producing and
delivering a product or service, from the very
beginning stage of sourcing the raw
materials to the final delivery of the product
or service to end-users.
Supply Chain
• The network of all the individuals,
organizations, resources, activities and
technology involved in the creation and sale
of a product.
• The entire system of producing and
delivering a product or service, from the very
beginning stage of sourcing the raw
materials to the final delivery of the product
or service to end-users.
Distributor vs wholesaler
Main entities in the supply chain
Chapter 1 – Introduction (GDP)
Distributor in the Pharma Sector
• The distribution plays a major role in
connecting the producer and consumer to
showcase the blend of products and their
strengths to them.
• The Pharma Company gives its franchise
rights to the merchants or advertising
experts who help in the bulk sales of
medicines, drugs, and other pharmaceutical
products in the country with direct or indirect
promotions for reselling of the pharma
products.
Distributor
manufacturers to pharmacies and other
providers.
• These companies play a crucial role in
ensuring that products reach consumers in a
timely and seamless manner.
Good Distribution Practice
• A set of standards for the sourcing, handling,
storage, and transportation of medicines for
human use and their active ingredients.
• A part of quality assurance which ensures
that the quality of a pharmaceutical product
is maintained through adequate control
throughout the numerous activities which
occur during the distribution process.
AO No. 2013- 0027
• Subject: Adoption and Implementation of the
World Health Organization Annex 5 Guide to
Good Distribution Practices (GDP) for
Pharmaceutical Products, and Annex 9 Guide
to Good Storage Practices for
Pharmaceuticals.
• WHO Technical Report Series, No. 937,
2006. Annex 5: Good Distribution Practices
for Pharmaceutical Products.
• The guidelines are intended to apply to all
steps in the distribution/ supply chain.
• The relevant sections should be considered
by various role players as applicable to their
particular role in the distribution process.
• The storage, trade and distribution of
pharmaceutical products are carried out by
various companies, institutions and
individuals.
• The nature of the risks involved, however, is
likely to be the same as those in the
manufacturing environment, e.g. mix-ups,
contamination and cross-contamination.
• The quality of pharmaceutical products can
be affected by a lack of adequate control
over the numerous activities which occur
during the distribution process.
Chapter 2 - Scope of Good distribution
Practice
• This document lays down guidelines for the
distribution of pharmaceutical products.
• Depending on the national and regional
legislation on pharmaceuticals, this guide
may also be applicable for veterinary
products administered to food-producing
animals.
• This document does not cover the
distribution of materials.
Chapter 3 – Glossary
• Definitions apply to the words and phrases
used in these guidelines.
• Although an effort has been made to use
standard definitions as far as possible, they
may have different meanings in other
contexts and documents.
The definitions provided below apply to the words
and phrases used in these guidelines. Although an
effort has been made to use standard definitions as
far as possible, they may have different meanings in
other contexts and documents. (World Health
Organization WHO Technical Report Series, No. 937,
2006.Annex 5):
1. agreement
➢ Arrangement undertaken by and
legally binding on parties.
2. auditing
➢ An independent and objective activity
designed to add value and improve
an organization’s operations by
helping an organization to accomplish
its objectives by using a systematic,
disciplined approach to evaluate and
improve the effectiveness of risk
management, control and
governance processes.
3. batch
➢ A defined quantity of pharmaceutical
products processed in a single
process or series of processes so that
it is expected to be homogeneous
(adapted from GMP).
4. batch number
➢ A distinctive combination of numbers
and/or letters which uniquely
identifies a batch, for example, on the
labels, its batch records and
corresponding certificates of analysis.
5. consignment (or delivery)
➢ The quantity of pharmaceutical
products supplied at one time in
response to a particular request or
order. A consignment may comprise
one or more packages or containers
and may include material belonging
to more than one batch (adapted
from GMP).
6. container
➢ The material employed in the
packaging of a pharmaceutical
product. Containers include primary,
secondary and transportation
containers. Containers are referred to
as primary if they are intended to be
in direct contact with the product.
Secondary containers are not
intended to be in direct contact with
the product.
7. contamination
➢ The undesired introduction of
impurities of a chemical or
microbiological nature, or of foreign
matter, into or on to a starting
material, intermediate or
pharmaceutical product during
handling, production, sampling,
packaging or repackaging, storage or
transport.
8. contract
➢ Business agreement for the supply of
goods or performance of work at a
specified price.
9. counterfeit
➢ A counterfeit medicine is one which is
deliberately and fraudulently
mislabeled with respect to identity
and/or source. Counterfeiting can
apply to both branded and generic
products and counterfeit products
and may include products with the
correct ingredients or with the wrong
ingredients, without active
ingredients, with insufficient active
ingredients or with fake packaging.
10. cross-contamination
➢ Contamination of a starting material,
intermediate product or fi nished
product with another starting
material or product during
production.
11. distribution
➢ The division and movement of
pharmaceutical products from the
premises of the manufacturer of such
products, or another central point, to
the end user thereof, or to an
intermediate point by means of
various transport methods, via
various storage and/or health
establishments.
12. excipient
➢ A substance or compound, other than
the active pharmaceutical ingredient
and packaging materials, that is
intended or designated to be used in
the manufacture of a pharmaceutical
product.
13. expiry date
➢ The date given on the individual
container (usually on the label) of a
product up to and including which the
product is expected to remain within
specifications, if stored correctly. It is
established for each batch by adding
the shelf-life to the date of
manufacture.
14. first expiry/first out (FEFO)
➢ A distribution procedure that ensures
that the stock with the earliest expiry
date is distributed and/or used before
an identical stock item with a later
expiry date is distributed and/or
used; earliest expiry/first out (EEFO)
has a similar meaning.
15. first in/first out (FIFO)
➢ A distribution procedure to ensure
that the oldest stock is distributed
and/or used before a newer and
identical stock item is distributed
and/or used.
16. good distribution practices (GDP)
➢ Good distribution practices are that
part of quality assurance that ensures
that the quality of a pharmaceutical
product is maintained by means of
adequate control of the numerous
activities which occur throughout the
distribution process.
17. good manufacturing practices (GMP)
➢ That part of quality assurance which
ensures that pharmaceutical
products are consistently produced
and controlled to the quality
standards appropriate to their
intended use and as required by the
marketing authorization.
18. good storage practices (GSP)
➢ Good storage practices are that part
of quality assurance that ensures that
the quality of pharmaceutical
products is maintained by means of
adequate control throughout the
storage thereof.
19. good trade and distribution practices (GTDP)
➢ Good trade and distribution practices
are that part of quality assurance that
ensures that the quality of
pharmaceutical products is
maintained by means of adequate
control throughout the numerous
activities which occur during the
trade and the distribution process.
20. health establishment
➢ A health establishment is the whole
or part of a public or private facility,
building or place, whether operated
for profit or not, that is operated or
designed to provide health care
services including the supply of
pharmaceutical products to the end
user.
21. importation
➢ The act of bringing or causing any
goods to be brought into a customs
territory (national territory, excluding
any free zone).
22. intermediate product
➢ Partly processed product that must
undergo further manufacturing steps
before it becomes a bulk product.
23. labelling
➢ Process of identifying a
pharmaceutical product including the
following information, as
 appropriate: name; active pharmaceutical products are of the
ingredient(s), type and amount; quality required for their intended
batch number; expiry date; special use.
storage conditions or handling 29. quality control
precautions; directions for use, ➢ Quality control covers all measures
warnings and precautions; names taken, including the setting of
and addresses of the manufacturer specifications, sampling, testing and
and/or the supplier (adapted from analytical clearance, to ensure that
GMP). starting materials, intermediates,
24. manufacture packaging materials and finished
➢ All operations of purchase of pharmaceutical products conform
materials and products, production, with established specifications for
quality control, release, storage and identity, strength, purity and other
distribution of pharmaceutical characteristics.
products, and the related controls. 30. quality system
25. material ➢ An appropriate infrastructure,
➢ A general term used to denote encompassing the organizational
starting materials (active structure, procedures, processes and
pharmaceutical ingredients and resources, and systematic actions
excipients), reagents, solvents, necessary to ensure adequate
process aids, intermediates, confidence that a product (or
packaging materials and labelling services) will satisfy given
materials. requirements for quality.
26. pharmaceutical product 31. quarantine
➢ Any medicine intended for human ➢ The status of pharmaceutical
use or veterinary product products isolated physically or by
administered to food-producing other effective means while a
animals, presented in its fi nished decision is awaited on their release,
dosage form, that is subject to rejection or reprocessing (adapted
control by pharmaceutical legislation from GMP).
in both the exporting state and the 32. sampling
importing state (adapted from GMP). ➢ Operations designed to obtain a
27. product recall representative portion of a
➢ Product recall is a process for pharmaceutical product, based on an
withdrawing or removing a appropriate statistical procedure, for
pharmaceutical product from the a defined purpose, e.g. acceptance of
pharmaceutical distribution chain consignments or batch release.
because of defects in the product or 33. shelf-life
complaints of serious adverse ➢ The period of time during which a
reactions to the product. The recall pharmaceutical product, if stored
might be initiated by the correctly, is expected to comply with
manufacturer, importer, distributor the specification as determined by
or a responsible agency. stability studies on a number of
28. quality assurance batches of the product. The shelf-life
➢ Quality assurance is a wide-ranging is used to establish the expiry date of
concept covering all matters that each batch.
individually or collectively influence 34. standard operating procedure (SOP)
the quality of a product. It is the ➢ An authorized, written procedure
totality of the arrangements made giving instructions for performing
with the object of ensuring that operations not necessarily specific to
 a given product but of a more general
nature (e.g. equipment operation,
maintenance and cleaning,
validation, cleaning of premises and
environmental control, sampling and
inspection). Certain SOPs may be
used to supplement product-specific
master and batch production
documentation.
35. storage
➢ The storing of pharmaceutical
products up to the point of use.
supplier Person or company providing
pharmaceutical products on request.
Suppliers include distributors,
manufacturers or traders.
36. transit
➢ The period during which
pharmaceutical products are in the
process of being carried, conveyed,
or transported across, over or
through a passage or route to reach
the destination.
37. validation
➢ Action of proving and documenting
that any process, procedure or
method actually and consistently
leads to the expected results.
38. vehicle
➢ Vehicle refers to trucks, vans, buses,
minibuses, cars, trailers, aircraft,
railway carriages, boats and other
means which are used to convey
pharmaceutical products.
Chapter 4 – Organization and management
• Appropriately authorized to perform the
intended function in terms of the applicable
legislation, and which can be held
accountable for its activities.
• There should be an adequate organizational
structure defined with the aid of an
organizational chart. The responsibility,
authority and interrelationships of all
personnel should be clearly indicated.
Chapter 5 – Personnel
• All personnel involved in distribution
activities should be trained inthe
requirements of GDP and be capable of
meeting these requirements.
• Key personnel involved in the distribution of
pharmaceutical products should have the
ability and experience appropriate to their
responsibility for ensuring that
pharmaceutical products are distributed
properly.
Chapter 6 – Quality Management
• Quality assurance serves as a management
tool.
• Quality management should include: - an
appropriate infrastructure or “quality
system”, encompassing the organizational
structure, procedures, processes and
resources; and
• — systematic actions necessary to ensure
adequate confidence that a product (or
service) and documentation will satisfy given
requirements for quality. The totality of these
actions is termed “quality assurance”.
Chapter 7 – Premises, warehousing and
storage
Good storage practice (GSP) is applicable in all
circumstances where pharmaceutical products are
stored and throughout the distribution process.
Storage Areas
• Precautions must be taken to prevent
unauthorized persons from entering storage
areas.
• Storage areas should be of sufficient capacity
to allow the orderly storage of the various
categories of pharmaceutical products.
• Storage areas should be designed or adapted
to ensure good storage conditions.
Storage Conditions
• Storage conditions for pharmaceutical
products should be in compliance with the
instructions on the label, which are based on
the results of stability testing.
Chapter 8 – Vehicles and equipment
• Vehicles and equipment used to distribute,
store or handle pharmaceutical products
 should be suitable for their use and Quality Risk Management
appropriately equipped.
Risk
• Dedicated vehicles and equipment should be
used, where possible, when handling • The possibility of causing harm and the
pharmaceutical products. severity of that harm are combined to form
risk.
Chapter 9 – Shipment containers and
o Personnel Risk
container labelling
o Product Risk
• Shipping containers may not need to bear o Patient or Public Risk
labels with full description of the identity of o Risk to the Corporation
the container’s content. o Risk to the outside environment
• Dedicated vehicles and equipment should be
History of Quality Risk Management
used, where possible, when handling
pharmaceutical products.

Chapter 10 – Dispatch

• Written procedures for the dispatch of

pharmaceutical products should be
established.
• Pharmaceutical products should only be sold
and/or distributed to persons or entities who
are entitled to acquire such products as
demonstrated by the applicable national,
regional and international legislation.

Chapter 11 – Transportation and products in

transit

• The transportation process should not

compromise the integrity and quality of
pharmaceutical products.
• A batch tracking system should be used to
enable specific batches to be traced during
the distribution process.
Chapter 12 – Documentation
• Written instructions and records should be
available which document all activities
relating to the distribution of pharmaceutical
products, including all applicable receipts
and issues.
• Procedures should be established and
maintained for the preparation, review,
approval, use of and control of changes to all
documents relating to the distribution
process.
Risk Management
• the continuing process to identify, analyze,
evaluate, and treat loss exposures and
monitor risk control and financial resources
to mitigate the adverse effects of loss.
• to identify potential problems before they
occur so that risk-handling activities may be
planned and invoked as needed across the
life of the product or project to mitigate
adverse impacts on achieving objectives.
Quality Risk Management
• A systematic process for the assessment,
control, communication, and review of risks
to the quality of the drug product across the
product lifecycle.
• quality of the drug product across the
product lifecycle.
 • the process of identifying, evaluating, and
mitigating recognized risks connected with
medicines and healthcare goods.
• has become an integral part of the quality
assurance and control system.
• valuable component of an effective quality
system.
Overview of a Typical QRM process (ICH Q9 –
QRM)
The ICH Q10 guidance explains the purpose of
technology transfer:
Note: ICH Q10 Guidelines – these guidelines are
followed for Tech transfer
Harm – damage to patient safety, product quality,
and business process; Adverse outcome/impact
Hazard – sourced of harm.
Technology Transfer and Scale-up
Manufacturing
Technology Transfer
• WHO guidelines (TRS 961, Annex 7) define
technology transfer as “a systematic
procedure that is followed in order to pass
the documented knowledge and experience
gained during development and/or
commercialization to an appropriate,
responsible and authorized party.
• It can also mean knowledge transfer about
existing products from one manufacturing
site to another by a facility change, a
company merger, an acquisition, or a shift to
a contract manufacturer (CMO).
• A technology transfer is a complex process
that involves different types of expertise.
Some of those are:
o Knowledge transfer
o Experience sharing
o Communications, and
o Inter and intra-company cooperation
on a large scale
Technology Transfer Goals
• “The goal of technology transfer activities is
to transfer product and process knowledge
between development and manufacturing,
and within or between manufacturing sites to
achieve product realization. This knowledge
forms the basis for the manufacturing
process, control strategy, process validation
approach, and ongoing continual
improvement.”
Technology Transfer team
• It is important that a technology transfer
team be comprised of cross-functional
subject matter experts, and the role and
responsibilities of each team member should
be clearly defined.
• A close relationship and good communication
between the donor and receiving sites is also
key for a successful technology transfer and
a fruitful long-term relationship, which can
last for the entirety of product development
and into the commercialization stage.
Glossary
1. acceptance criteria
➢ Measurable terms under which a test
result will be considered acceptable.
2. active pharmaceutical ingredient (API)
➢ Any substance or mixture of
substances intended to be used in the
manufacture of a pharmaceutical
dosage form and that, when so used,
 becomes an active ingredient of that
pharmaceutical dosage form. Such
substances are intended to furnish
pharmacological activity or other
direct effect in the diagnosis, cure,
mitigation, treatment, or prevention
of disease or to affect the structure
and function of the body.
3. bracketing
➢ An experimental design to test only
the extremes of, for example, dosage
strength. The design assumes that
the extremes will be representative of
all the samples between the
extremes.
4. change control (C/C)
➢ A formal system by which qualified
representatives of appropriate
disciplines review proposed or actual
changes that might affect a validated
status. The intent is to determine the
need for action that would ensure
that the system is maintained in a
validated state.
5. commissioning
➢ The setting up, adjustment and
testing of equipment or a system to
ensure that it meets all the
requirements, as specified in the user
requirement specification, and
capacities as specified by the
designer or developer.
Commissioning is carried out before
qualification and validation.
6. control strategy
➢ A planned set of controls, derived
from current product and process
understanding, that assures process
performance and product quality.
The controls can include parameters
and attributes related to materials
and components related to drug
substances and drug product
materials and components, facility
and equipment operating conditions,
in-process controls, finished product
specifi cations, and the associated
methods and frequency of monitoring
and control (6).
7. corrective action (C/A)
➢ Any action to be taken when the
results of monitoring at a critical
control point indicate a loss of
control.
8. critical
➢ Having the potential to impact on
product quality or performance in a
significant way.
9. critical control point (CCP)
A step at which control can be applied
and is essential to prevent or
eliminate a pharmaceutical quality
hazard or to reduce it to an
acceptable level
10. design qualification (DQ)
➢ Documented evidence that the
premises, supporting systems,
utilities, equipment and processes
have been designed in accordance
with the requirements of good
manufacturing practices (GMP).
11. design space
➢ The multidimensional combination
and interaction of input variables
(e.g. material attributes) and process
parameters have been demonstrated
to provide assurance of quality (7).
12. drug master fi le (DMF)
➢ Detailed information concerning a
specific facility, process or product
submitted to the medicine’s
regulatory authority, intended for
incorporation into the application for
marketing authorization.
13. finished pharmaceutical product (FPP)
➢ A product that has undergone all
stages of production, including
packaging in its final container and
labelling. An FPP may contain one or
more APIs.
14. gap analysis
➢ Identification of critical elements of a
process which are available at the SU
but are missing from the RU.
15. good manufacturing practices (GMP)
➢ That part of quality assurance which
ensures that pharmaceutical
products are consistently produced
and controlled to the quality
 standards appropriate to their
intended use and as required by the
marketing authorization (3).
16. in-process control (IPC)
➢ Checks performed during production
in order to monitor and, if necessary,
to adjust the process to ensure that
the product conforms to its
specifications. The control of the
environment or equipment may also
be regarded as a part of in-process
control.
17. installation qualification (IQ)
➢ The performance of tests to ensure
that the installations (such as
machines, measuring devices,
utilities and manufacturing areas)
used in a manufacturing process are
appropriately selected and correctly
installed and operate in accordance
with established specifications.
18. intercompany transfer
➢ A transfer of technology between
sites of different companies.
19. intracompany transfer
➢ A transfer of technology between
sites of the same group of
companies.
20. operational qualification (OQ)
➢ Documented verification that the
system or subsystem performs as
intended over all anticipated
operating ranges.
21. performance qualification (PQ)
➢ Documented verification that the
equipment or system operates
consistently and gives reproducibility
within defined specifications and
parameters for prolonged periods.
(In the context of systems, the term
“process validation” may also be
used.)
22. process validation
➢ Documented evidence which
provides a high degree of assurance
that a specific process will
consistently result in a product that
meets its predetermined
specifications and quality
characteristics.
23. qualification
➢ Action of proving and documenting
that any premises, systems and
equipment are properly installed,
and/or work correctly and lead to the
expected results. Qualification is
often a part (the initial stage) of
validation, but the individual
qualification steps alone do not
constitute process validation.
24. qualification batches Those batches
produced by the RU to demonstrate its ability
to reproduce the product (1).
25. quality assurance (QA)
➢ Quality assurance is a wide-ranging
concept covering all matters that
individually or collectively influence
the quality of a product. It is the
totality of the arrangements made
with the objective of ensuring that
pharmaceutical products are of the
quality required for their intended
use.
26. quality control (QC)
➢ Quality control covers all measures
taken, including the setting of
specifications, sampling, testing and
analytical clearance, to ensure that
starting materials, intermediates,
packaging materials and finished
pharmaceutical products conform
with established specifications for
identity, strength, purity and other
characteristics.
27. quality planning
➢ Part of quality management focused
on setting quality objectives and
specifying necessary operational
processes and related resources to
fulfil the quality objectives (6).
28. quality policy
➢ Overall intentions and direction of an
organization related to quality as
formally expressed by senior
management (6).
29. quality risk management (QRM)
➢ Quality risk management is a
systematic process for the
assessment, control, communication
and review of risks to the quality of
 the pharmaceutical product
throughout the product life-cycle.
30. receiving unit (RU)
➢ The involved disciplines at an
organization where a designated
product, process or method is
expected to be transferred.
31. sending unit (SU)
➢ The involved disciplines at an
organization from where a including the acceptance criteria for
designated product, process or
method is expected to be transferred.
32. spiking
➢ The addition of a known amount of a
compound to a standard, sample or
placebo, typically for the purpose of
confirming the performance of an
analytical procedure.
33. standard operating procedure (SOP)
➢ An authorized written procedure
giving instructions for performing
operations not necessarily specific to
a given product or material (e.g.
equipment operation, maintenance
and cleaning, validation, cleaning of
premises and environmental control,
sampling and inspection). Certain
SOPs may be used to supplement
product-specific master and batch
production documentation.
34. technology transfer report
➢ A documented summary of a specific
technology transfer project listing
procedures, acceptance criteria,
results achieved and conclusions. Any
deviation should be discussed and
justifi ed.
35. validation
➢ Action of proving and documenting
that any process, procedure or
method actually and consistently
leads to the expected results.
36. validation master plan (VMP)
➢ A high-level document that
establishes an umbrella validation
plan for the entire project and
summarizes the manufacturer’s
overall philosophy and approach, to
be used for establishing performance
adequacy. It provides information on
the manufacturer’s validation work
program and defines details of and
timescales for the validation work to
be performed, including a statement
of the responsibilities of those
implementing the plan.
37. validation protocol (or plan) (VP)
➢ A document describing the activities
to be performed in a validation,
the approval of a manufacturing
process — or a part thereof — for
routine use.
38. validation report (VR)
➢ A document in which the records,
results and evaluation of a completed
validation program are assembled
and summarized. It may also contain
proposals for the improvement of
processes and or equipment.
Organization and Management
• There should be a project management
plan which identifies and controls all the
necessary activities identified at the start of
the undertaking.
• The transfer protocol should list the
intended sequential stages of the transfer.
• The protocol should include:
• Technology transfer plan: This describes
all the activities to be transferred, the steps
to be taken for the transfer, the
responsibilities of each group at each site,
and the expected outcome.
• Detailed analytical methods: Analytical
methods are one of the first elements of a
manufacturing process to be transferred.
They are also the foundation of technology
transfer success because the results of the
analyses are used for comparability
assessments.
• Manufacturing process description or
batch: The manufacturing batch record is
the most crucial document in describing the
manufacturing process. WHO guidelines on
transfer of technology in pharmaceutical
manufacturing (Annex 7, WHO Technical
Report Series, No. 961, 2011)
• Manufacturing process description or
batch: The manufacturing process transfer
 team should always include a technical
specialist from the donor site, as sometimes
the knowhow is not well-documented in the
batch record.
• Critical process parameters (CPPs): The
CPPs and any other important parameters
must be identified and taken into account for
a successful transfer. WHO guidelines on
transfer of technology in pharmaceutical
manufacturing (Annex 7, WHO Technical
Report Series, No. 961, 2011)
• Critical quality attributes (CQAs):
Having an understanding and control over
the product’s CQAs is important during a
technology transfer.
• Technical gap analysis: This is a formal
documentation of the assessment of known
and potential gaps between the donor and
receiving sites’ capabilities and of their
readiness for the transfer. WHO guidelines
on transfer of technology in pharmaceutical
manufacturing (Annex 7, WHO Technical
Report Series, No. 961, 2011)
• Adequate change control management
system: Any changes or adjustments made
to the process or equipment should be
documented, assessed, and justified with
regards to their potential impact on the CQAs
and the Quality Target Product Profile
(QTPP).
Production: Transfer (processing, packaging
and cleaning)
• The RU should be able to accommodate the
intended production capacity.
Starting Materials
• The specifications and relevant functional
characteristics of the starting materials (APIs
and excipients) to be used at the RU should
be consistent with materials used at the SU.
Active pharmaceutical ingredients (API)
• The SU should provide the RU with the open
(applicant’s) part of the API master file
(APIMF or drug master file (DMF) or active
substance master file (ASMF)), or equivalent
information and any relevant additional
information on the API of importance for the
manufacture of the pharmaceutical product.
Excipients
• The excipients to be used have a potential
impact on the final product. Their
specifications and relevant functional
characteristics should, therefore, be made
available by the SU for transfer to the RU
site.
Packaging
• Information on packaging to be transferred
from the SU to the RU includes specifications
for a suitable container or closure system.
Cleaning
• Adequate cleaning procedures are essential
during manufacturing process.
• In order for the RU to define its cleaning
strategy the SU should provide information
on cleaning at the SU to minimize cross-
contamination due to residues from previous
manufacturing steps, operator exposure and
environmental impact.
Quality Control: Analytical Method Transfer
Transfer of analytical methods should accommodate
all the analytical testing required to demonstrate
compliance of the product to be transferred with the
registered specification.
Premises and Equipment
Premises
• The SU should provide information to the RU
on the layout, construction and finish of
buildings and services which have an impact
on the product, process or method to be
transferred.
Equipment
• The SU should provide a list of equipment,
makes and models involved in the
manufacture, filling, packing and or control
of the product, process or method to be
transferred, together with existing
qualification and validation documentation.
 Documentation

• The documented evidence that the transfer

of technology has been considered
successful should be formalized and stated in
a technology transfer summary report.

Commercial Manufacturing

• A stage of drug production whereby

approved therapies are commercialized —
meaning they’re manufactured at scale,
marketed to consumers and healthcare
organizations, and sold.
• The ultimate goal of commercial
manufacturing is to take the established
processes and figure out how to optimize
them for mass production without
compromising quality or safety.
• Importance:
o Commercial manufacturing is
important because it is the final
crucial step after therapies are
approved by regulatory bodies for
mass production.

What happens during Commercial

manufacturing:

• Commercial manufacturing kicks off with a

full FDA review.
• Manufacturing begins.
• Batch production.
• Batch is tested.
• Batch is released