A German pharmaceutical manufacturer asked Zamann Pharma Support to strengthen its Equipment Qualification (EQ) compliance with EMA and FDA expectations.
During the project, Zamann identified a critical weakness: the company used GMP equipment from vendors that it had not properly qualified.
Major suppliers had not undergone audits. Quality agreements did not clearly define documentation responsibilities. In addition, FAT/SAT records were incomplete, software suppliers lacked GAMP assessments, and several vendor validation packages were missing.
As a result, qualification teams faced missing records, unclear design information, repeated qualification work, and uncertain supplier responsibilities.
Weak supplier qualification had therefore become a risk across the entire Equipment Qualification lifecycle.
Our team assessed supplier risks, reviewed vendor documentation, defined qualification requirements, connected supplier evidence to the EQ lifecycle, and proposed a structured supplier requalification approach.
Our team supports the planning, execution, and maintenance of qualification and validation activities, including IQ, OQ, and PQ, to keep GMP-regulated systems compliant and under control.
Missing vendor documentation can break the evidence chain between equipment design and qualification. Without approved design specifications, installation requirements, calibration certificates, or FAT/SAT records, the qualification team may not have enough evidence to confirm correct installation or define reliable OQ tests. In this case, documentation gaps delayed IQ by six weeks and contributed to repeated OQ activities.
The risk increases when automated equipment includes software but the company does not assess the supplier and system under the relevant GAMP category. Gaps become more significant when teams also fail to evaluate audit trails, software configuration, electronic records, or required software documentation. As a result, the equipment may complete mechanical qualification while its computerized functions remain insufficiently assessed.
Critical supplier records should connect directly to the URS, risk assessment, qualification protocols, and traceability matrix. Depending on the equipment, this evidence can include Design Specifications, Functional Descriptions, installation requirements, calibration and material certificates, FAT/SAT reports, and software configuration records. This traceability helps the qualification team show how supplier evidence supports equipment requirements and qualification testing.
