Information sheet #2

How to use FT-IR spectroscopy compliant to

regulations in pharmaceutical industry

1. Compliance to Good Manufacturing Practice (GMP/cGMP)

Good Manufacturing Practice is a guideline that applies to all companies that manufacture
pharmaceutical products. GMP aims to minimize errors during the complete production process
to protect consumers from purchasing ineffective or even dangerous pharmaceutical products.
The GMP regulations are defined by the US Food and Drug Administration (FDA), the European
Medicines Agency (EMA), and the World Health Organization (WHO). Consequently, the GMP
regulations have to be followed worldwide.
The GMP guideline requires validation of analytical instruments including FT-IR spectrometers.
This validation procedure normally is divided into three segments:
Installation Qualification (IQ) – includes description of requirements and safety features of the system
Operational Qualification (OQ) – verification that the system operates as specified
Performance Qualification (PQ) – control that the required specifications are met under routine
operation
Bruker is prepared to fulfill all demands for a complete GMP compliance. The following items and
services are required:

 Validated OPUS software (part of every Bruker spectrometer system)

 OPUS Validation Program (OVP) for automated Operational and Performance Qualification
(OQ/PQ) (part of every Bruker spectrometer system).
 S010/x System Validation Manual. The manual assists the validation (DQ/IQ/OQ/PQ) of the basic
spectrometer system, extensions (e.g. external accessories), and the OPUS spectroscopic software.
 S020/x Validation Service. A certified service engineer performs IQ/OQ/PQ of the basic spectro-
meter system and extensions (e.g. external accessories) during installation of the instrument.
Further options are available to ease and secure continuous GMP compliance:

 S9xxxx Various service and maintenance contracts including re-validation services for the
basic spectrometer system and extensions (e.g. external accessories).
 S905-OPVAL Extension of a maintenance or service contract by update to the latest OPUS
release version and the System Validation Manual.

2. Compliance with US, European and Japanese Pharmacopeia

National and international pharmacopeias describe pharmaceutical regulations about quality,
storage, control and naming of pharmaceutical drugs. Also the substances, materials and methods
used for production and verification are described.
As infrared spectroscopy is a commonly used analytical method for testing pharmaceutical raw
materials and products the US, European and Japanese pharmacopeias request specific standard
materials and procedures for the qualification of the IR-spectrometer system. All companies produ-
cing pharmaceutical drugs for these markets have to comply with the respective pharmacopeia.
Bruker provides a certified reference standard incorporated in the spectrometers Internal Valida-
tion Unit and automatic test routines to fully comply with the regulations of US, European and
Japanese Pharmacopeia. Required:

 S030/M Option to test an MIR spectrometer according to PhEur 2.2.24 and PhJP 2.25.
Includes
- Certification of standard reference material polystyrene BRM1921
- O/PHEUR2224 software package with instrument qualification protocols for PhEur 2.2.24
and PhJP 2.25.
Option to secure continuous compliance with US, European and Japanese Pharmacopeia:

S030/MR Recertification of standard polystyrene reference material BRM1921 according to
PhEur 2.2.24 after expiry of the certification period.

3. Compliance with 21 CFR Part 11

Title 21 CFR Part 11 are regulations issued by the US Food and Drug Administration (FDA) that
define standards under which electronic records and signatures can be considered to be equivalent
to paper records. It applies to all companies that sell pharmaceutical products to the US market.
The OPUS software is designed to fully comply with 21 CFR Part 11. Required:

 O/VAL, OPUS/VALIDATION package for 21 CFR part 11 compliance of the OPUS spectrosco-
pic software. Contains functionality to apply electronic signatures on spectral data, experiment
files and evaluation methods.

4. Compliance to Good Laboratory Practice (GLP)

The principles of Good Laboratory Practice (GLP) have been promoted by the Organisation for
Economic Co-operation and Development (OECD) and are internationally accepted. The purpose
of GLP is to ensure the quality and validity of data from studies that were performed to deter-
mine the safety of chemical products including pharmaceuticals.
The OPUS spectroscopic software contains all features to allow generation of analytical data in
full compliance with the GLP principles:

 Extended user and password management

 Access control, automatic system audit trail
 Audit trail for spectra and evaluation methods
 Original data cannot be deleted or overwritten
 All data (spectra, evaluation, results, reports) stored in a single file to guarantee data integrity
and simplify archiving
 All functions in a single software

Bruker Optics Inc. Bruker Optik GmbH Bruker Hong Kong Ltd.
Billerica, MA · USA Ettlingen · Deutschland Hong Kong
Phone +1 (978) 439-9899 Phone +49 (7243) 504-2000 Phone +852 2796-6100
Fax +1 (978) 663-9177 Fax +49 (7243) 504-2050 Fax +852 2796-6109
info.bopt.us@bruker.com info.bopt.de@bruker.com hk@brukeroptics.com.hk

www.bruker.com/optics
Bruker Optics is continually improving its products and reserves the right to change specifications without notice.
© 2015 Bruker Optics BOPT-4000775-01