YalePharma
Corporation
Validation
Facility
Commissioning, Qualification,
and Validation
U.S. biotech and pharmaceutical
facilities must comply
with the FDA's current
Good Manufacturing Practices
(cGMPs). The validation
effort documents that
a facility's design meets
the intent of the cGMP's.
We can help you design
your facility from the
ground up. Our key competencies
lie in state-of-the-art
laboratories, cGMP areas,
pilot plants, facility
automation and advanced
process controls and specialized
utility systems e.g. for
sterile manufacture.
PSC consultants are experts
at Commissioning new facilities,
performing HVAC Validation,
and validating other systems
as part of a facility
qualification/validation
Utilities/Facility Systems:
Water Systems
USP Purified
Water-for-Injection
(WFI)
Reverse Osmosis
Deionized
Ozonation
Clean Steam
Clean-in-Place/Steam-in-Place
Compressed Gases
Air
Carbon Dioxide
Oxygen
Nitrogen
Helium
* Ethanol Supply Systems
* Process Glycol Systems
* HVAC
* Chilled Water Systems
* Airflow Studies
* Clean Room
* Class 100
* Class 10K
* Class 100K
* Building Management
System (BMS) and Process
Monitoring
* Emergency Generator
and Uninterruptible Power
Supply
* Manufacturing Requirements
Planning (MRP)
* Adverse Event tracking
and Reporting Systems
Equipment
Validation
Equipment Validation
ensures that an instrument
is appropriate for its
intended use. Typical
validation phases are:
* Design qualification
(DQ) for setting functional
and performance specifications
(operational specifications).
* Installation qualification
(IQ) for performing and
documenting the installation
in the selected user environment.
* Operational qualification
(OQ) for testing the equipment
in the selected user environment
to ensure that it meets
the previously defined
functional and performance
specifications.
* Performance qualifications
(PQ) for testing that
the system consistently
performs as intended for
the selected application.
Design Qualification
Design qualification
(DQ) defines the functional
and operational requirement
and specifications of
the instrument and details
the conscious decisions
in the selection of the
supplier. DQ should enable
them to be successfully
implemented for the intended
application and to meet
business requirements.
Errors in DQ can have
a tremendous technical
and business impact, and
therefore a sufficient
amount of time and resources
should be invested in
the DQ phase. PSC consultants
can facilitate requirements
gathering and validation
to ensure that the equipment
your company selects will
meet your needs.
Installation Qualification
Installation qualification
establishes that the instrument
is received as designed
and specified, that it
is properly installed
in the selected environment,
and that this environment
is suitable for the operation
and use of the instrument.
Installation qualification
includes:
* Ensure that all equipment,
software, spare parts,
accessories are received
in good condition.
* Check documentation
for completeness (operating
manuals, maintenance instructions,
standard operating procedures
for testing, safety and
validation certificates).
* Install hardware (computer,
equipment, fittings and
tubings for fluid connections,
columns in HPLC and GC,
power cables, data flow
and instrument control
cables).
* Switch on the instruments
and ensure that all modules
power up and perform an
electronic self-test.
* Install software on
computer following the
manufacturer's recommendation.
* Verify correct software
installation, e.g., are
all files loaded.
* Configure peripherals,
e.g., printers and equipment
modules.
Operational Qualification
Operational or equipment
qualification (OQ) is
the process of demonstrating
that an instrument will
function according to
its operational specification
in the selected environment.
Performance Qualification
Performance qualification
(PQ) is the process of
demonstrating that an
instrument or equipment
consistently performs
according to the specification
appropriate for its routine
use.
PQ can mean system suitability
testing, where critical
key system performance
characteristics are measured
and compared with documented,
preset limits. For example,
a well characterized standard
can be injected five or
six times and the standard
deviation of amounts are
then compared with a predefined
value.
Performance qualification
includes:
* Definition of performance
criteria and test procedures.
* Selection of critical
parameters with some allowance
to drift out of predefined
specifications.
* Determination of the
test intervals, e.g.,
o Everyday.
o Every time the system
is used.
o Before, between and
after a series of runs.
* Define corrective actions
on what to do if the system
does not meet the established
criteria.
Temperature Distribution
and/or Penetration Studies
The YalePharma MD performs
temperature mapping studies
utilizing Kaye Instruments
metrology equipment. These
studies are conducted
to demonstrate that temperature
controlled equipment is
maintaining the specified
temperature ranges. The
Kaye application software
can be configured to perform
data calculations such
as minimum, maximum, average,
lethality etc. Representative
equipment tested includes
autocalves, lypholizers,
refrigerators, freezers
and incubators.
PSC can validate all
types of manufacturing,
packaging, shipping, and
laboratory equipment,
including:
* Environmental Chamber
* Laminar Flow Hood
* Water System - HPW,
WFI
* Incubator
* Clean Room
* Autoclave
* Depyro Oven
* Refrigerator
* Freezer
* Centrifuge
* Dissolution Tank
* Drying Oven
* Fluid Bed Coater
* Heat Tunnel
* Induction Sealer
* Capper
* Labeler
* Cottoner
* Neckbander
* Retorquer
* Filler
* Fluoro Plate Reader
* Spectro Plate Reader
* Endotoxin Analyzer
* UV/Vis Spectrometer
* Tablet Press
* Encapsulator
* Metal Detector
* PLC
* DCS
* Nitrogen Gas
* HPLC
* Ion Chromatography
* Mass Spec
* LCMS
* RF
* Microwave
* NMR
* IR
* NIR
* Gas Chromatography
* Reactor
* Compressed Air
* Cooling Tower
* Mixing Room
* Dehumidifier
* Milling Equip
* Pasteurizer
* Fermentor
* Atomic Absorption
* Lyophilizer
* Imaging System
* Crystallography
* Flow Cytometer
* Hematology Analyzer
* Chemistry Analyzer
* Thermocycler
* Lab on Chip
Process
Validation
A process is the controlled
interaction of components,
equipment, environment,
software and personnel
to produce a product or
achieve an acceptable
outcome. YalePharma MD
provides the consulting
expertise to demonstrate
through appropriate testing
that the finished product
produced by a specified
process meets all release
requirements for quality.
The process validation
protocol describes a plan
that demonstrates consistency
and reliability in processing
and confirms that all
component, processing
and product specifications
are appropriate and attainable
under ideal and challenged
conditions. The Process
Validation effort typically
occurs after the Installation
Qualification (IQ), Operational
Qualification (OQ), and
(when required) a Performance
Qualification (PQ) have
been satisfactorily completed.
Successful process validation
requires thorough process
development, identification
of controlled and critical
parameters and in-process
and final product specifications.
Typically at a minimum
three (3) consecutive
lots of product meeting
the established quality
specifications are necessary
for process validation.
These three consecutive
lots are completed at
the boundaries of critical
parameters.
Cleaning
Validation
Development of cleaning
programs in general is
a rigorous, time consuming
and often frustrating
experience. The objective
of cleaning validation
is to ensure that a specific
cleaning process will
consistently clean to
predetermined limits so
as to prevent contaminants
(product or cleaning process
related) from leaving
residues that will adulterate
and adversely affect the
safety and quality of
the next product manufactured.
Cleaning validation is
documented proof that
one can consistently and
effectively cleanse a
system or equipment item.
YalePharma MD has extensive
experience in developing
meaningful acceptance
criteria and ensuring
the execution is conducted
in an orderly manner.
Our experienced staff
can provide services in
Cleaning validation. Our
highly skilled individuals
can ensure that equipment-cleaning
procedures are removing
residues to predetermined
levels of acceptability.
These individuals are
trained to:
* Understand regulatory
(FDA) requirements, guidelines
and expectations
* Select and evaluate
effective cleaning methods
and processes
* Establish residue limits
and calculate sample acceptance
criteria
* Select sampling and
analytical methods
* Simplify the cleaning
validation program.
Computer
Systems and Software Validation
Computerized Systems
that perform regulated
functions must be qualified
or validated. Computerized
Systems may include networks
(wired and wireless),
workstations, operating
system software, application
software, instrument software,
equipment software, and
interfaces with other
computerized systems.
PSC offers a complete
range of services for
your computer validation
needs. We EXCEL at SAP,
TrackWise, Delta V, and
custom software validations!
We offer complete outsourced
Quality Assurance services
for software implementation
and validation projects!
* Preparation of Software
Validation documents:
o User Requirements
Specifications (URS)
o Functional Requirements
Specifications (FRS)
o Software Requirements
Specifications (SRS)
o Validation Master
Plan
o Installation Qualification
(IQ)
o Operational Qualification
(OQ)
o Performance Qualification
(PQ)
o Risk Assessment
o Hazard Analysis
o Traceability Matrix
o Validation SOPs
* Execution of Validation
Protocols and resolution
of deviations
* Network Qualification
* Server Qualification
* 21 CFR Part 11 Gap Analysis,
remediation, and validation
cGMP
Audits
YalePharma MD’s cGMP audit
process will ensure that
your facility meets all
applicable regulatory
requirements. At YalePharma MD,
we have expertise in cGMP
norms and will audit the
suppliers' manufacturing
facilities for compliance
to cGMP, where required
assistance to implement
cGMP will be offered.
To completely fulfill
your needs, a YalePharma MD Audit
Coordinator can be assigned
to your project to ensure
full compliance with cGMPs
and NIH (National Institute
of Health) guidelines.
Contract Manufacturer
Audits
We conduct in-depth Manufacturer
Audits to assure the manufacturer
has the ability to maintain
full compliance with cGMPs
and fulfill your needs.
We also provide services
for evaluating, selecting
and monitoring a contract
manufacturer.
Contract Laboratory Audits
We determine and monitor
the cGMP compliance throughout
the period of the contract
laboratory activities.
Compliance to cGMP is
required for all testing
activities associated
with the manufacturer
for human use.
Supplier/Vendor Audits
We conduct inspection
audits with each supplier/vendor
of critical raw materials,
components and supplies
to assure the supplier/vendor’s
compliance to cGMPs. In
addition, we can assist
you in developing a vendor
audit program and can
participate with your
personnel on audits.
Quality/Product Audits
We conduct in-depth Quality/Product
Audits to assess the completeness
of the company’s quality
system and audit trails
by defining the product
critical items, enabling
the audit team to focus
on issues that affect
product quality.
Computer System Audits
We provide guidance on
how computer systems should
be validated to meet cGMP
requirements and/or provide
highly independent audits
to assure your computer
systems are in compliance
with the FDA requirements.
General cGMP Compliance
Audits
We provide cGMP Compliance
Audits to you on a one
time or annual basis.
We conduct highly independent
and impartial audits and
provide reports to you
with suggestions for improvement.
cGMP Audit Training
We train your personnel
and help them to prepare
and pass regulatory and
corporate audits and inspections
successfully.
GCP
Audits
GCP audits are becoming
increasingly important
to all parties involved
in clinical research and
are an essential part
of ICH GCP. They help
evaluate the effectiveness
of all monitoring activities,
assess the quality of
clinical data and help
prepare for regulatory
inspections. At YalePharma MD,
we offer GCP auditing
services covering one
or more of the following
aspects of clinical studies:
Investigator Audits/
Facility Audit
We verify and assess
through audit procedures
compliance with FDA regulations
to assure that data submitted
to the FDA in specific
studies is substantiated
by records. These audits
are conducted to standard
operating procedures to
assure compliance with
ICH GCP and/or FDA regulations.
This audit includes clinical
and laboratory facilities,
procedures and practices.
Pre-Regulatory Inspection
Audits
We conduct Pre-Regulatory
Inspection Audits, working
with quality and regulatory
specialists in your organization
to analyze current policies,
practices, SOPs and to
observe daily work behaviors.
We will produce observations
and suggestions which,
when correctly implemented,
can better prepare your
organization for an FDA
audit.
Contract Suppliers Audits
(Clinical Laboratories/
Contract Research Organization/
Off-site archiving facilities)
We independently audit
contract suppliers to
assure that they can offer
you the quality service
you expect. This audit
involves those organizations
or corporations which
have entered into contractual
agreement with a sponsor
to perform one or more
obligations for the sponsor.
Clinical Study Report
Audits
We audit clinical study
records at the site, including
comparing case report
forms with the source
documents and reviewing
clinical supply accountability
records, biological sample
shipment records, and
other study files. We
offer you highly independent
audit services to assure
you the report has been
written in compliance
with ICH GCP and correctly
reports and summarizes
the data.
Database Audits
We conduct database audits
to ensure that data is
handled in a secure manner,
accurately transferred
to databases, maintained
with appropriate documentation
and to assure that your
database truly reflects
the data captured on the
Case Report Forms.
Computer System Audits
We provide guidance on
how computer systems should
be validated to meet cGCP
requirements and/or provide
highly independent audits
to assure that your computer
systems are in compliance
with the FDA requirements.
Standard Operating Procedure
Writing
We offer an SOP writing/review
service to assure compliance
with current GCP requirements.
We evaluate the efficiency
and feasibility of your
procedures.
GCP and Audit Training
We train your monitors
so that they reach high
quality monitoring standards
and work in full compliance
with the applicable SOPs
and national regulations
as well as ICH-GCP guidelines.
GLP
Audits
YalePharma MD offers a diverse
range of GLP auditing
services that can help
your company ensure continuing
compliance with regulatory
requirements and prepare
for a regulatory audit.
We have extensive experience
in performing highly independent
and impartial third-party
audits for our clients
within the pharmaceutical
and biotechnology industries.
Pre-Regulatory Inspection
Audits
We conduct Pre-Regulatory
Inspection Audits, working
with quality and regulatory
specialists in your organization
to analyze current policies,
practices, SOPs and to
observe daily work behaviors.
We will produce observations
and suggestions which,
when correctly implemented,
can better prepare your
organization for an FDA
audit.
Laboratory/Facility Audits
We verify and assess
through audit procedures
compliance with FDA regulations
to assure the laboratory/facility
is in compliance with
the appropriate guidelines
and regulations. These
audits are conducted to
standard operating procedures
to assure compliance.
This audit includes clinical
and laboratory facilities,
procedures and practices.
Contract Research Organization
Audits
We independently audit
Contract Research Organizations
to assure that they can
offer you the quality
service you expect. In
addition we can monitor
specific studies placed
at a Contract Research
Organization.
Computer System Audits
We provide guidance on
how computer systems should
be validated to meet cGLP
requirements and/or provide
highly independent audits
to assure your computer
systems are in compliance
with the FDA requirements.
General cGLP Compliance
Audits
We provide cGLP Compliance
Audits to you on a one
time or annual basis.
We conduct highly independent
and impartial audits and
provide reports to you
with suggestions for improvement.
cGLP Audit Training
We train your personnel
and help them to prepare
and pass regulatory and
corporate audits and inspections
successfully.
ISO
Audits
Outsourcing your ISO
audit to a professional
auditor is cost effective
and convenient. Internal
Audits usually take too
much time and staff resources
from your company and,
in addition, professional
auditors have more experience
than in-house auditors.
At YalePharma MD, with our
experienced professional
auditors, we have the
skills to make your ISO
internal audit value-added.
Our auditors are on the
knowledge forefront of
the changes to the ISO
standards and we will
help you improve processes
and customer satisfaction
while ensuring compliance
with the ISO standards.
Suppliers/Vendors Audits
We conduct Suppliers/Vendors
audits with each supplier/vendor
to assure the supplier/vendor’s
compliance to ISO standards.
In addition, we can assist
you in developing a vendor
audit program and can
participate with your
personnel on audits.
Pre-Registration Audits
We conduct Pre-Registration
Audits, working with quality
and regulatory specialists
in your organization to
analyze current policies
and practices, and to
observe daily work behaviors.
We will produce observations
and suggestions which,
when correctly implemented,
can better prepare your
organization prior to
a registration audit or
a surveillance audit by
a registrar.
ISO Audit Training
We train your internal
auditors and coach them
in audit techniques in
order to help you to reduce
costs and improve audit
values.
Computer
Systems Audit
PSC employs the PDA Process
Model for Auditing Suppliers
of Computer Products and
Services. The PDA Process
Model includes the use
of very detailed data
collection tools to ensure
thorough and specific
audit results. Over a
dozen of our staff members
are PDA certified auditors,
and have audited many
software developers and
electronic data capture
suppliers. We approach
the client being audited
in a non-threatening,
professional manner, and
provide audit reports
that are detailed and
descriptive.
