2a Review On Applications of Gamp 5 in Pharmaceutical Industries

Copyright © 2013 By IYPF
All rights reserved

Open Access Contents
Int. J. Drug Dev. & Res.
| July-September 2013 | Vol. 5 | Issue 3 | ISSN 0975-9344 |
www.ijddr.in
A Review on applications of GAMP -5 in Pharmaceutical Industries
P. Lalasa
Abstract:
The new Good automated manufacturing practices (GAMP)-5
guidelines were released February 2008 at the ISPE(International Society for
N. Vishal Gupta* Pharmaceutical Engineering) Manufacturing Excellence Conference in Tampa,
Florida. These guidelines are the latest, up-to-date thinking in the approach to
Raghunandan H.V validation of GxP computerized systems. The purpose of the guidelines is to
“provide a cost effective framework of good practice to ensure that
computerized systems are fit for use and compliant with regulation.”
Palleti Lakshmi Prathusha There are five key concepts to GAMP 5:
• Product and Process Understanding.
Kailash Athkuri • Lifecycle approach within QMS.
• Scalable Lifecycle Activities.
Pharmaceutical Quality • Science Based Quality Risk Management.
Assurance Group, Department • Leveraging Supplier Involvement.
of Pharmaceutics, Understanding the product and process is critical in determining system
JSS College of Pharmacy, JSS requirements and for making science and risk-based decisions to ensure that the
University, system is “fit for use.” In determining “fit for use,” attention should be focused on
Shri Shivarathreeshwara Nagar, “those aspects that are critical to patient safety, product quality, and data
Review Paper
integrity.” Defining a lifecycle approach to a computerized system has been
Mysore-570015, Karnataka,
Page 4
expanded from GAMP 4 to include all phases and activities from concept and
India implementation through operation and retirement. Some applications of GAMP- 5
in Pharmaceutical industries like Monitoring manufacturing, production and
Corresponding Authors: storage environments in the pharmaceutical industry, Monitoring the autoclaving
N. Vishal Gupta process in the pharmaceutical industry, Water purification in the pharmaceutical
Dept. of Pharmaceutics, JSS industry, Freeze drying in the pharmaceutical industry
College of Pharmacy, Shri
Shivarathreeswara Nagar,
Mysore - 570 015, Karnataka,
K
ey words: Computerized systems, Guidelines, Risk- based approach, Validation,
Patient safety, Product quality.
India;
Email: vkguptajss@gmail.com
interior principles of GAMP is that quality cannot
INTRODUCTION:
be tested into a batch of product but must be
Good Automated Manufacturing Practice built into each stage of the manufacturing
(GAMP) is a technical subcommittee of the process. As a result, GAMP covers all aspects of
International Society for Pharmaceutical production; from the raw materials, facility and
Engineering (ISPE), a set of guidelines for equipment to the training and hygiene of staff.
manufacturers and users of automated systems in Standard operating procedures (SOPs) are
the pharmaceutical industry. More specifically, essential for processes that can affect the quality
the ISPE's guide Good Automated Manufacturing of the finished product.[1]
Practice (GAMP) guide for Validation of ISPE has published a series of good practice
Automated Systems in Pharmaceutical guides for the industry on several topics involved in
Manufacture describes a set of principles and drug manufacturing. The most well-known is The
procedures that help ensure that pharmaceutical Good Automated Manufacturing Practice
products have the required quality. One of the
Covered in Scopus & Embase, Elsevier Int. J. Drug Dev. & Res., July-September 2013, 5 (3): 4-16
© 2013 N. Vishal Gupta et al, publisher and licensee IYPF. This is an Open Access article which permits unrestricted
noncommercial use, provided the original work is properly cited.
(GAMP) guide for Validation of Automated However, a general application of several broad
Systems in Pharmaceutical Manufacture. concepts can be used successfully as guidance
The new GAMP-5 guidelines were released for validation. These broad concepts provide an
February 2008 at the ISPE Manufacturing acceptable framework for building a
Excellence Conference in Tampa, Florida. These comprehensive approach to software validation.
N. Vishal Gupta et al; A Review on applications of GAMP -5 in Pharmaceutical Industries
guidelines are the latest, up-to-date thinking in the [25]
approach to validation of GxP computerized The software categories according to GAMP

systems. The purpose of the guidelines is to classes are described in Table- 1
“provide a cost effective framework of good
practice to ensure that computerized systems are Hardware Categorization:
fit for use and compliant with regulation.” [1] GAMP recognizes two levels of hardware
History: Hardware Category 1 - Standard Hardware
GAMP itself was founded in 1991 in the United Components
Kingdom to deal with the evolving U.S. Food and The majority of the hardware used by regulated
Drug Administration expectations for Good companies will fall into this category. Standard
Manufacturing Practice (GMP) compliance of hardware components should be documented
manufacturing and related systems. GAMP including manufacturer or supplier details, and
published its first guidance in 1994. Soon version numbers. Correct installation and
afterwards the organization entered into a connection of components should be verified. The
Page 5
partnership with ISPE, formally becoming part of model, version number and, where available,
ISPE in 2000. GAMP has enjoyed the support of serial number, of preassembled hardware should
numerous regulatory authorities over the years be recorded. [25]
spanning the United States, Europe, and Japan Hardware Category 2 - Custom Built Hardware
and is now a recognized good practice Components
worldwide. [1] These requirements are in addition to those of
Gamp 5 objective: standard hardware components. Custom items of
GAMP5 guidance aims to achieve computerized hardware should have a Design Specification (DS)
systems that are fit for intended use and meet and be subjected to acceptance testing. The
current regulatory requirements, by building upon approach to supplier assessment should be risk-
existing industry good practice in an efficient and based and documented. In most cases a Supplier
effective manner.[1,2] Audit should be performed for custom hardware
development. [25]
Concepts:[2]
DISCUSSION:
GAMP wants to make it clear that GAMP 5 is “not
Software categories a prescriptive method or standard, but rather
Due to the great variety of medical devices, provides pragmatic guidance, approaches and
processes, and manufacturing facilities, it is not tools for the practitioner.” This means that
possible to state in one document all of the companies should use these guidelines along with
specific validation elements that are applicable. other guidelines and industry best practice to
determine the best approach for validating GxP There may be other factors that companies may
computerized systems. want to consider when making assessments, but
There are five key concepts to GAMP 5 (Figure 1) this process should be documented and follow
1. Product and Process Understanding established policies and procedures. By
2. Lifecycle approach within QMS conducting this assessment companies can scale
3. Scalable Lifecycle Activities their validation effort and other lifecycle activities
4. Science Based Quality Risk Management to the appropriate levels.[13, 14]
5. Leveraging Supplier Involvement Because of the use of a “scaled” approach,
GAMP has reassessed their V-model and has
1) Product and Process Understanding “generalized” the model to account for other
Understanding the product and process is critical possible approaches. (Figure 2)
in determining system requirements and for This model can be expanded or even reduced
making science and risk-based decisions to ensure depending on the scale or scope of the system
that the system is “fit for use.” In determining “fit being validated.
for use,” attention should be focused on “those
aspects that are critical to patient safety, product 4) Science Based Quality Risk Management
quality, and data integrity.” Science Based Quality Risk Management allows
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companies to focus on critical aspects of the
2) Lifecycle Approach within a QMS computerized system and develop controls to
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Defining a lifecycle approach to a computerized mitigate those risks. This is where a clear
system has been expanded from GAMP 4 to understanding of the product and process is
include all phases and activities from concept critical to determine potential risks to patient
and implementation through operation and safety, product quality, and data integrity.[15]
retirement. These activities should be defined They acknowledge that this is not the only
within the quality management system (QMS). This approach and that each company needs to
allows for a consistent approach across all decide what approach best works for its intended
systems. use.
There are four major phases defined for any Risks that have been identified can be mitigated
system: by:
1. Concept 3. Operation • Elimination by design
2. Project 4. Retirement • Reduction to suitable level
• Verification to demonstrate that the risks are
3) Scalable Lifecycle Activities managed to an acceptable level
Within the GAMP 5 guidelines GAMP outlines that GAMP 5 describes and talks about a five step
lifecycle activities should be scaled according to: process for risk management based on ICH
• System impact on patient safety, product Guidelines in figure 3.[2]
quality, and data integrity (Risk Assessment) 5) Leveraging supplier involvement
• System complexity and novelty Regulated companies regularly involve suppliers
• Outcome of supplier assessment throughout the system lifecycle. Suppliers have
the knowledge, experience, and documentation Quality by design (QBD).
to assist companies throughout the system’s Continuous improvement with in Quality
lifecycle. management system (QMS).
GAMP 5 suggests regulated companies need to Critical quality attributes (CQA).
maximize that involvement to “determine how Improving GxP compliance efficiency.
best to use supplier documentation, including Configurable systems and development

existing test documentation, to avoid wasteful models.
effort and duplication. Use of existing documentation and
Documentation should be assessed for suitability, knowledge.
accuracy, and completeness. There should be Effective supplier relationships.
flexibility regarding acceptable format, structure Scalable approach to GxP compliance
and documentation practices.” Science based quality risk management
Suppliers can be used to assist companies with: system.
1. Gathering requirements Life cycle approach within QMS.
2. Creation of functional and other
specifications GAMP 5 illustrates the specification, design, and
3. System configuration verification process ( Figure 4)[31]
4. Testing SOME APPLICATIONS OF GAMP-5
5. Support 1. Monitoring manufacturing, production and
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6. Maintenance storage environments in the pharmaceutical
7. System retirement industry.
It is important to remember that the regulated 2. Monitoring the autoclaving process in the
company has the responsibility for the pharmaceutical industry.
documentation, approval, and compliance of 3. Water purification in the pharmaceutical
each element of the computerized system industry.
lifecycle. With increased involvement of the 4. Freeze drying in the pharmaceutical
supplier in the lifecycle, regulated companies industry
need to assess that the supplier has processes in 1) Monitoring manufacturing, production and
place to ensure quality of the product. GAMP has storage environments in the pharmaceutical
included a section in GAMP 5 dedicated to industry. [3]
supplier activities to assist suppliers in Provides independent verification and
understanding the needs of their customers. [26, 27] validation of the manufacture, production and
GAMP 5 sets the main requirements for the use of storage processes
computerized systems in pharmaceutical The conditions under which pharmaceutical
applications: [31] products are manufactured and stored can have
Patient safety, product quality and data a major impact on their quality. Factors such as
integrity. temperature, humidity, air quality, time and
Effective governance to achieve and production process characteristics can all have a
maintain GxP compliance.
significant impact on the final quality of a product that the correct temperatures are maintained.
or batch of products. Exactly how this is achieved varies according to
the type and size of refrigerator being used and
For the purposes of traceability, it is necessary to the type of product in question. High-risk products,
adhere to GAMP 5 guidelines to accurately for example, must be maintained between 2°C
record every stage in the production lifecycle of a and 8°C and stored in precisely controlled
product, encompassing not just the refrigerators. For operators of a storage plant, it is
manufacturing process but also the storage and necessary not only to ensure that products are
distribution stages. In doing so, manufacturers can stored at the right temperature, but also that the
prove to have acted in accordance with best refrigeration plant is capable of accurately
practice by building in quality from the outset and maintaining that temperature.
designing failure out of the process.[10] Adopted by many countries worldwide,
the UK’s Medicines and Healthcare products
Manufacture, storage and distribution Regulatory Agency (MHRA) regulations stipulate
GAMP guidelines advise that the that the performance of refrigeration plant used
manufacture, storage and distribution stages of to store pharmaceutical products needs to be
pharmaceutical products are monitored to ensure regularly checked. To achieve this, operators
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that any facilities involved meet the required need to map their refrigeration equipment using
standards. Of the various parameters that need to one or more thermometers and /or temperature
Page 8
be carefully controlled, temperature and humidity probes to ensure that temperature is uniformly
are perhaps the two most critical. maintained. The resulting temperatures need to
All parties involved in the manufacture, be recorded as proof of compliance with the
storage and distribution of pharmaceutical required standards. The requirement to accurately
products are required to record and keep details map the storage temperatures also extends
of temperatures during these processes. Efficient beyond refrigeration equipment to include
handling and processing of sensitive materials is warehouses and controlled temperature rooms.
critical to the profitable manufacture of
pharmaceutical products. GAMP encourages 2) Monitoring the autoclaving process in the
manufacturers to use measurement techniques pharmaceutical industry.[7]
that allow a better understanding of the Provides independent verification and
interaction between material properties, validation monitoring of the autoclaving process
equipment design and operating conditions, in Sterilization permits the re-use of pharmaceutical
processes such as capsule forming and drying, equipment such as instruments, utensils, lab
pan coating, parenteral manufacturing, sterile equipment and media preparation, and is
filling, spray and powder drying, and tablet necessary to eliminate transmissible agents such
compression. as spores, bacteria and viruses. It is possible to kill
For many products requiring storage in some microorganisms with chemicals, irradiation,
cool conditions, refrigeration plant is widely used, and dry heat but the most effective and
which needs to be carefully monitored to ensure inexpensive method is with saturated steam.
The most popular piece of equipment for points’ for any temperature below the required
use in steam sterilization processes is the sterilization temperature. The higher the
autoclave. An autoclave is a pressurized vessel temperature the faster the ‘killing points’ accrue.
that that uses steam to apply pressure and heat to The result is an equivalent time at the sterilization
a load placed inside. The advantage of using an temperature. This can shorten total autoclave
autoclave is that it can reach temperatures higher cycle times by taking into account the killing
than boiling water alone, so it can kill not only temperatures prior to the required sterilization
bacteria but also bacterial spores, which tend to temperature being reached. It is important to
be resistant. Autoclaves commonly use steam perform a regular calibration check and to be
heated to 115–134°C (250–273°F). To achieve able to perform full calibration adjustment for the
sterility, a holding time of at least 30 minutes at system inputs as it is important to verify that the
115°C, 15 minutes at 121°C (250°F) or 3 minutes at measurements made are reliable.
134°C (273°F) is required. Verification of the The system that records the data also
process is usually recorded on chartor paperless independently triggers warning and active alarms
recorders, though the latter is becoming more should the accepted process parameters be
widespread. These recorders will need to be exceeded. In this instance it is usual for a 134°C
validated to GAMP guidelines, according to the sterilizing temperature to have a high alarm at
FDA and other authorizing bodies. 137°C. The use of independent recorders for
The control functions of an autoclave are monitoring the autoclave gives confidence that
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normally performed using an integrated control the process has performed as required and is
system from the manufacturer. However, it is usual usually part of the product release
that key parameters are independently recorded documentation.
against time, including temperature and pressure.
The number of temperature and pressure points 3) Water purification in the pharmaceutical
that are independently recorded varies by the size industry:[4]
of the autoclave to ensure that a representative Provides independent verification and
record is retained. Typically three temperature validation of the water purification process.
and one pressure signals are used. These are Water is a major commodity used by the
totally independent sensors from the control pharmaceutical industry. Different grades of water
system. One temperature sensor is typically quality are required according to the
located in the ‘drain’ or the coolest location; one pharmaceutical process. The United States
in the load of the product being sterilized; and Pharmacopoeia (USP) and the European
one in the ‘free space’ (typically the hottest Pharmacopoeia (EP) are the governing bodies
location). The pressure signal is there to cross that issue guidelines for the manufacture of drugs
correlate the temperature, as pressure is directly to their respective markets. Amongst these
proportional to temperature for saturated steam. guidelines are regulations, legally enforceable by
Some installations look to have the mathematical the FDA and European equivalents (such as the
calculation for F0. This takes the temperature and MHRA), for the purification of different grades of
uses an exponential calculation to give ‘killing water used in the pharmaceutical processes:
Purified water – is used in preparation of guidelines, including conductivity meters, pH
medicinal products other than those that meters, and temperature sensors and recording
require the use of water to be sterile. equipment. An independent monitoring and
Highly purified water - intended for use in recording system should therefore be put in place
the preparation of products where water of to provide sufficient and secure data to ensure
high biological quality is needed, except these processes meet the various specific
where water for injection is required. standards. As there are a number of methods for
Water for injection – the purest grade of bulk producing purified water of different grades there
water monographed by the USP and EP and are also a variety of different parameters that
is found in the manufacture of parenteral, need to be monitored and controlled, including
ophthalmic and inhalation products. conductivity, pH, temperature and pressure,
The validation and qualification of water amongst others. It is important to perform a
purification systems are a fundamental part of regular calibration check and to be able to
Good Automated Manufacturing Practice perform full calibration adjustment for the system
(GAMP) and form an integral part of the GAMP inputs, as it is important to verify that the
inspection. Different grades of water are measurements made are reliable.
produced according to USP and EP requirements, The system that records the data should
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usually by: distillation; reverse osmosis; also independently trigger warning and active
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deionisation; or ultrafiltration. All of these alarms, should the accepted process parameters
processes need to be validated and recorded be exceeded. These often incorporate a time
according to specific standards. delay and / or a hysteresis. This only triggers the
Each set of guidelines outline legal alarm once the parameter has exceeded
requirements for the chemical content of each acceptable levels by a certain amount of time,
grade of water, including a three stage which helps prevent nuisance alarms.
conductivity test for inorganic compounds that The use of independent recorders for production
will determine pH and total organic oxygen (TOC) of purified water allows specific, independent and
levels. The FDA states that implicit in the term easily validated processes to be monitored
“Purified Water” is that it has some reasonable, without the requirement of validating an entire
objective level of purity. TOC testing allows for complex Distributed Control System (DCS). It shows
evaluating impurities in water besides those which exactly what has happened, together with details
are inorganic anions and cations. Although there of any alarms in real-time.
are no absolute microbial standards for water,
GAMP regulations require that appropriate 4) Freeze drying in the pharmaceutical industry: [5]
specifications be established and monitored. Provides independent verification and
Action or alert limits must be based upon validation monitoring of the freeze drying process.
validation data and must be set low enough to Freeze drying is a technique used by
signal significant changes from normal operating pharmaceutical manufacturers to derive dry
conditions. In all these instances a range of product from aqueous solutions. Originally
instrumentation is required to meet GAMP developed during the 1940s, the technique
produces a dry product which can be readily The controller takes the difference between the
reconstituted to its original form by adding water output and the reference value and uses it to
when required. As such it is as an ideal way of change the inputs to the system to help
prolonging the life of pharmaceutical products, compensate for the difference. The result is a
particularly where this may involve long periods of more dynamic and precise control of the freeze
storage and transit prior to use. drying process, with the ability to address any
The freeze drying process itself entails first unexpected fluctuations in process conditions.
freezing the aqueous form of the product on The control functions of a freeze dryer are
shelves in a vacuum chamber, after which the normally performed using an integrated control
chamber is evacuated. At the next stage, the system from the manufacturer. However, it is usual
Primary drying process, the product is slowly that key parameters are independently recorded
warmed up over a number of hours to boil off the against time, including humidity, temperature and
liquid, with any moisture being evacuated pressure (or vacuum). The system that records the
throughout the process through a cold data also independently triggers warning and
condenser. active alarms should the accepted process
This is then followed by a Secondary drying parameters be exceeded. These often
process, during which the temperature in the incorporate a time delay. This then triggers the
chamber is raised to help remove any residual alarm once the parameter has exceeded
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water. As a final check that the product is dry, a acceptable levels by a certain amount of time,
pressure rise test is carried out, with any more than which helps prevent nuisance. It is important to
a fractional rise in pressure indicating that there is perform a regular calibration check and to be
still some residual liquid present .Any control able to perform full calibration adjustment for the
system used for a freeze drying application should system inputs as it is important to verify that the
ideally be capable of automatically adjusting the measurements made are reliable.
process to maintain the ideal conditions. To satisfy FDA requirements, all data from
Traditionally, open loop control systems have the freeze drying process should be recorded.
been used, with the freezing and heating Where data recorders are used, the requirements
temperatures and the chamber pressure being of the International Society of Pharmaceutical
controlled according to a specific profile. Engineers (ISPE)’s Good Automated
However, this approach has several drawbacks, Manufacturing Practice (GAMP) will also apply,
including the inability to cope with temperature including the stipulation that any recording
variations outside of the set profile. With no way of equipment has to be validated for use in
accelerating the process if conditions change, pharmaceutical processes. A recorder with
the overall freeze drying period is also prolonged. Ethernet connectivity allows historical recorded
For optimum control of the freeze drying data and alarm and audit trail information to be
process, a closed loop control system should retrieved automatically to a central database
instead be used. Data from the pressure and where archive and analysis, if required, can take
temperature sensors is fed back to the controller place.
where it is compared against a reference value.
Any electronic recording equipment also PIC/S, and other groups have been touting, such
has to be compliant with the FDA’s 21 CFR Part 11 as -Using a scientific risked based approach to
rule. A key aspect of 21 CFR Part 11 is its focus on validation and leveraging vendor documentation,
security, particularly relating to the prevention of regulated companies can reduce the time and
data tampering and the ability to identify specific cost necessary for validation and maintain their
individuals and events involved in the production systems in a compliant state.
and / or data management processes. [21]
Table 1: Describes the software categories
The use of independent recorders for
according to GAMP classes [2]
monitoring the freeze dryer allows specific,
GAMP
independent and easily validated processes to be CATEGORY VALIDATION ACTION
CLASS
monitored without the requirement of validating 1 Operating systems Record version
Instruments and Record configuration
an entire complex Distributed Control System 2
controllers. and calibration
Audit supplier, validate
(DCS). It shows exactly what has happened and
any bespoke code.
3 Configurable
alarms, in real-time. Apply full life cycle
packages.
requirements.
Audit supplier and code,
System that the code
validate any bespoke
or part
CONCLUSION 4
of the code are
code. Configurations
apply full life cycle
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configurable.
requirements.
While there are new revolutionary concepts in
System utilizing
GAMP 5, it does bring together the latest industry custom or bespoke Audit supplier, validate
Page 12
5 code which develop all code, apply full life

and regulatory thinking in GxP computerized predicate rules cycle requirements.
system validation into one concise guidance. By information
using the basic concepts that the GAMP, FDA,
Lifecycle approach within QMS

Scalable Lifecycle Activities
Science Based Quality Risk Management
Leveraging Supplier Involvement
Figure 1: GAMP-5: concepts of GAMP- 5 [1, 2]
Product and process understanding
PLANNING REPORTING
SPECIFICATIONS VERIFICATIONS
CONFIGURATION AND
CODING
Supporting process including risk management
Figure 2: Flow chart of V-model. [1, 2]
STEP 1 Perform initial risk assessment and determine system impact
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STEP 2 Identify functions with impact on patient safety, product quality and data
integrity
STEP 3 Perform functional risk assessment and identify controls
STEP 4 Implement and verify appropriate controls
STEP 5 Review risks and monitor controls
Figure 3: Five step process for risk management based on ICH Guidelines [1,2]
Good Engineering Practice
Product
Knowledge
Acceptance Operation
Requirements Specification and Release and
Verification
Process and Design Continuous
Knowledge improvement
Regulatory Risk management

Requirement
s
Design review
Company
Quality
Change management
Figure 4: The Specification, Design, and Verification Process – Diagram from ASTM E2500 [ 31]
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31) Rathore Garvendra S, Gaur Ajay1, Rathore
Shashi, Shekhawat Madhu and Gupta Roop N.
Validation of fluidized bed processor (mini glatt).
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Page 16
Article History:------------------------
Date of Submission: 18-05-2013
Date of Acceptance: 25-05-2013
Conflict of Interest: NIL
Source of Support: NONE

2a Review On Applications of Gamp 5 in Pharmaceutical Industries

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guidelines are the latest, up-to-date thinking in the [25]

approach to validation of GxP computerized The software categories according to GAMP

best to use supplier documentation, including Configurable systems and development

5 code which develop all code, apply full life

using the basic concepts that the GAMP, FDA,

Lifecycle approach within QMS

Leveraging Supplier Involvement

Figure 1: GAMP-5: concepts of GAMP- 5 [1, 2]

Product and process understanding

Supporting process including risk management

Figure 2: Flow chart of V-model. [1, 2]

STEP 1 Perform initial risk assessment and determine system impact

STEP 3 Perform functional risk assessment and identify controls

STEP 4 Implement and verify appropriate controls

STEP 5 Review risks and monitor controls

Regulatory Risk management

1) GAMP®5: A Risk-Based Approach to Compliant _RandC_007-EN.pdf.

Science Manufacturing. Sue horwood recommendation-on-computerised-systems.pdf

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