Pharmaceuticals and quality control
Evidence of balance suitability for raw-material weighing, sample preparation and product checks in GMP environments.
QPAC · WEIGHING EQUIPMENT QUALIFICATION
QPAC: IQ, OQ and PQ qualification of weighing equipment
QPAC is PRECIZ's weighing-equipment qualification package combining IQ (installation qualification), OQ (operational qualification) and PQ (performance qualification). It provides documented evidence of equipment suitability and can be ordered separately or alongside calibration.
IQInstallationOQOperationPQAccess
FOR YOUR PROCESS
Who needs QPAC — and why?
For organisations requiring documented evidence of weighing equipment suitability, especially when weighing affects product quality, analytical reliability or batch release decisions.
GLP laboratories
Documented control of equipment affecting the reliability and repeatability of study results.
Analysis and development
Assess suitability for methods, small sample weights and required tolerances.
Biotechnology and medical devices
Equipment qualification where weighing affects critical product characteristics and is required by the quality system.
Food, cosmetics and chemical industries
Support dosing, recipe repeatability and evidence of process requirements.
The need and scope depend on your process, risk and quality system requirements. QPAC is the name of our service package, not a standalone standard or universally mandatory certificate.
QUALITY AND RISK REDUCTION
What does qualification provide?
Lower risk
Identify unsuitable installation, settings and equipment limitations before they affect results.
Clear criteria for use
Know which tasks and operating ranges the balance has been tested for.
Easier audits
Test results, findings and the suitability assessment are brought together in the documentation.
Less rework and waste
Reduce the risk of dosing errors, repeat analyses, scrap and deviation investigations.
IQ · OQ · PQ
Three steps to documented suitability
IQGLP / GMP
Installation Qualification
IQ · Installation
Is the scale installed correctly?
Check compliance with the order, identification, instrument and peripheral condition, installation environment and supporting documentation.
Documented review of installation and deviations.
OQ
Operational Qualification
OQ · Operation
Does the scale operate as required?
Check balance settings, functions and metrological information, and document the operating demonstration and user training.
Evidence of operation against defined criteria.
PQ
Performance Qualification
PQ · Performance in your process
Is it suitable for your actual work?
Relate testing to your working masses, tolerances and use. According to the agreed scope, assess measurement performance, repeatability and relevant influences against agreed acceptance criteria.
Assessment of suitability for the specified use.
Calibration and QPAC: connect measurements to process requirements
Calibration
Calibration provides measurement results, errors and uncertainty. These data help assess measurement quality.
More about calibration →A standalone service adapted to your process
QPAC is also available separately from calibration. Agree requirements, tests and acceptance criteria for installation, operation and use.
During planning, we review your current measurement documentation and identify additional tests required. QPAC also addresses installation, functional operation and suitability for the agreed intended use.
EVIDENCE OF COMPLETION
Qualification report
Following IQ, OQ and PQ, we prepare a final report with findings and a suitability assessment. It is usually linked to the calibration certificate to keep qualification and measurement evidence together.
The report covers the agreed scope, test results, observed deviations and assessment against acceptance criteria.
USP 〈41〉
How small a sample can you weigh reliably?
The number of displayed decimal places alone does not determine the smallest sample that can be weighed with the required result quality.
USP minimum weight certificate
The package also includes a minimum weight certificate under USP Chapter 41. It states the smallest suitable weighing quantity based on repeatability testing and the applied criterion.
The value applies to a particular balance and test conditions. It does not by itself confirm all USP requirements. We align use of USP 〈41〉 with the weighing purpose; the chapter is not a universal requirement for every production scale.
QUALIFICATION PLANNING
When is the right time for QPAC?
The need to repeat individual tests is determined by the change and risk assessment.
Before first use of a new balance in a demanding or regulated process.
When introducing an existing balance into a new process.
After relocation, significant repair or configuration changes.
When operating ranges, tolerances or intended use change.
When existing documentation does not clearly demonstrate equipment suitability.
DIGITAL INSTRUMENT RECORD
Soter · Documentation for the right scale
Link qualification reports, calibration certificates and documentation to the instrument's digital record. Identification, service history and planned events stay together.
A QR code gives the user access to the specific scale's documentation according to their permissions.
Discover Soter →FREQUENTLY ASKED QUESTIONS
Clear answers before you book.
What does QPAC include?
QPAC combines installation qualification (IQ), operational qualification (OQ) and performance qualification for your process (PQ). It also includes a USP 41 minimum weight certificate. Testing and documentation are defined for the balance and process.
Is QPAC part of calibration?
QPAC is a standalone qualification service available separately or with calibration. Calibration provides measurement results and uncertainty; QPAC also checks installation, operation and suitability for intended use. The qualification report is usually linked to the calibration certificate.
When do I need IQ, OQ and PQ?
Use IQ, OQ and PQ when you need documented evidence of correct installation, operation within the intended range and suitability for your actual process. This is particularly relevant before use in GMP and GLP environments or where your quality system requires qualification. After relocation, major intervention or a change of use, assess which tests need repeating based on risk. Adapt the scope to your equipment and process.
What information is needed to plan qualification?
Provide a process description, equipment details, requirements, acceptance criteria and any existing protocols. These define the work and documentation.
Does QPAC include USP minimum weight?
Yes. Alongside the qualification report, QPAC includes a minimum weight certificate under USP Chapter 41. The value applies to the tested instrument and conditions, not universally to all balances of the same model.
QPAC · PRECIZ
A checked scale. A documented basis for your decisions.
Send the scale details and describe your process. Together, we define the qualification scope, tests and documentation.