From the very first conceptual idea to a package for all water treatment services, lasting many years, we support our customer with our comprehensive service package. Being a flexible, medium-sized company allows us to provide in-house solutions for most service areas. Special services as well as those low in demand are only awarded to certified cooperation partners who have had our trust for many years.
- Design according GMP rules
- Commissioning of storage and distribution systems for purified water cGMP
- AISI316L stainless steel recirculation loops using orbital welding using ASME-BPE standardized materials
- Process automation and HMI with validated procedure cCFR21 rules
- DQ, IQ, OQ validation documentation cGMP, EP, FDA
- Authorized service, consumables and spare parts
Good manufacturing practices (GMP) are the practices required in order to conform to the guidelines recommended by agencies that control authorization and licensing for manufacture and sale of food, drug products, and active pharmaceutical products. These guidelines provide minimum requirements that a pharmaceutical or a food product manufacturer must meet to assure that the products are of high quality and do not pose any risk to the consumer or public.
ASME BPE (American Society of Mechanical Engineers: Bioprocessing Equipment) is an international standard developed as an aid for the design and construction of equipment intended for use in the manufacturing of biopharmaceuticals. The standard is approved as an American National Standard by the American National Standards Institute (ANSI).
For industries involved in pharmaceutical and health care products, or even laboratories, product quality is paramount and minute inconsistencies can have disastrous results. Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) are an essential part of quality assurance through equipment validation.
What Do IQ, OQ and PQ Mean?
IQ OQ PQ protocols are ways of establishing that the equipment which is being used or installed will offer a high degree of quality assurance, so that manufacturing processes will consistently produce products that meet predetermined quality requirements. To understand these terms better, let’s look at each of them one by one:
Installation Qualification (IQ)
Any new equipment is first validated to check if it is capable of producing the desired results through Design Qualification (DQ), but its performance in a real-world scenario depends on the installation procedure that is followed. Installation Qualification (IQ) verifies that the instrument or equipment being qualified, as well as its sub-systems and any ancillary systems, have been delivered, installed and configured in accordance with the manufacturer’s specifications or installation checklist.
In addition to this, any cGMP requirements that pertain to the IQ and the approach used for IQ is thoroughly-documented in the Validation Master Plan (VMP).
For successful qualification, the installation must meet manufacturer requirements, like:
· Installation location and floor space
· Power, gas supply and other energy sources
· Environmental and operating conditions
· Unpacking instruments and checking for damage
· Cross-checking contents against the packing list
· Documentation of computer-controlled instrumentation
· Checking software-installation and basic accessibility
· Installation ancillary instruments and options
· Verifying connections and communication with peripheral units
· Recording firmware versions and serial numbers
· Tagging instruments with IQ stickers
· Recording calibration and validation dates of equipment used for IQ
· Gathering all manuals and certificates of conformity
Operational Qualification (OQ)
Once each protocol of the IQ phase has been met, Operational qualification (OQ) is performed to check that the equipment’s performance is consistent with the user requirement specification, within the manufacturer-specified operating ranges. During the OQ phase, all the items in the test plan are tested individually and their performance documented. This is a prerequisite for technical acceptance of the equipment and the facility, so it can only be performed once the IQ has been successful.
Apart from qualification after the initial installation, requalification also needs to be carried out after any major maintenance work or modifications have been made to equipment, or as part of a regular quality assurance schedule.
The main purpose of OQ is to identify and inspect features of the equipment that can influence final product quality, like:
· Display units and signaling LEDs
· Temperature controls and fluctuations
· Overheating and low-temperature protection systems and alarms
· Pressure/Vacuum controlling systems
· CO2 controlling systems
· Humidity measuring and controlling systems
· Fan and fan-speed controllers
· Servo motors and air flap controllers
· Card readers and access controllers
· Temperature distribution in accordance with DIN 12880: 2007-05
Performance Qualification (PQ)
PQ is the final step in qualification processes for equipment, and this step involves verifying and documenting that the equipment is working reproducibly within a specified working range. Rather than testing each instrument individually, they are all tested together as part of a partial or overall process. Before the qualification begins, a detailed test plan is created, based on the process description.
Process Performance Qualification (PPQ) protocol is a vital part of process validation and qualification, which is used to ensure ongoing product quality by documenting performance over a period of time for a certain process.
FDA guidelines recommend including the following criteria as part of PQ and PPQ protocols:
· Manufacturing conditions like equipment limits, operating parameters and component inputs
· A list of the data that should be recorded or analyzed during tests, calibration and validation
· Tests that need to be performed to ensure consistent quality at various steps of production
· A sampling plan which outlines the sampling methods used during and in between production batches
· Analysis methodology for making data, scientific and risk-oriented decisions based on statistical data
· Defining variability limits and contingency plans for handling non-conformance
· Approval of the PPQ protocol by relevant departments
Qualification of Equipment
Equipment qualification through DQ IQ OQ PQ practices is a part of Good Manufacturing Practice (GMP), through which manufacturers and laboratories can ensure that their equipment delivers consistent quality. It reduces the margin for errors, so the product quality can be maintained within industry standards or regulatory authority requirements. When qualification of equipment is not needed very frequently, performing it in-house might not be feasible, so smaller laboratories might benefit from scheduling external equipment validation services on a regular basis instead.
As we understand it , customer relations even after operational startup is also teamwork, because only through instruction and training of operating personnel ensure high customer satisfaction and a long service life for the system.
The associated maintenance service is defined in parallel to the time for startup.
Numerous optional services are offered as part of the standard basic and primary maintenance; these can also be combined in a complete service package:
- basic and primary maintenance as a customer-specific service
- user training of operating personnel
- critical tap water analysis by in-house or contract laboratory
- calibration service for all measurement points subject to calibration
- certified reference measurment using ASTM standards
- provision and management of system-specific test equipment
- remote maintenance via modem
- development of operation models
- customer-specific spare parts provision