We have multiple Cooperation manufacturing locations that are registered with the FDA and operate under cGMP. Our OEM Cooperation are currently working to enhance their current quality systems that would meet the requirements of a recognized standard.
Supply Chain(Suppliers)
Our supplier's (materials services) can be qualified using a combination of criteria such as, assessment questionnaires, on-site audits, historical performance (quality, on-time delivery) and/or third party accreditation. A supplier may becomeRejected after non-compliance with the BerrChem expectations. New and alternate suppliers are qualified as necessary to maintain product supply, purity and competitiveness.
QA / QC Staffing
The BerrChem have many Quality Assurance / Quality Control program staffs
Process Control
- Procedures Documentation exists for providing appropriate instructions for producing and testing final product. If changes to the manufacturing or testing process is warranted the work instruction document(s) will reflect the procedural change and approval.
- Critical equipment, defined as equipment where monitoring and output are controlled and recorded, is maintained in a calibration and testing program. Where applicable, traceable standards (e.g. NIST) are utilized. Documented procedures exist for equipment operation, calibration and maintenance, and can also include how equipment is cleaned. Equipment and usage records are maintained and available. Equipment tags are also employed to further indicate equipment calibration and maintenance status.
- Quality Records Where appropriate quality records for a product lifecycle within BerrChem are maintained and available, quality records can include: customer inquiries including orders and complaints, raw material information, in-process manufacturing and testing data, packaging, final quality analysis, batch disposition, training and equipment. A product and batch numbering system is employed to allow for traceability throughout the entire process.
- Nonconformance When a batch is determined to be nonconforming to product specifications, the batch is flagged in our electronic systems and may also be physically labeled and/or segregated to reflect this blocked status so as to prevent shipment. Procedures exist to describe this process.
Quality System Details
Strategic Plan and Management Review
BerrChem embarked on the process of developing and implementing a comprehensive strategic plan which included an emphasis on enhancing the Quality Management System. This plan is continuously evaluated and adjusted to ensure BerrChem objectives are achieved. In addition, many locations also conduct Management Reviews of their site Quality Management System at prescribed intervals.
Quality Manual
The majority of locations within BerrChem have a Quality Manual, which provides information on the elements of the Quality Management System for that location including the sequences and interactions of the primary processes.
Document Control
Quality Management System policies and procedures are maintained under document control. Procedures include administration, manufacturing, analytical methods, equipment operation and others.
Training
BerrChem have established training programs that include core and job specific requirements. Core training can include quality system, safety and developmental topics. In addition to job training, each position has a written job description that describes the necessary educational and experience qualifications to adequately perform the required tasks.
Corrective and Preventive Action
Each site has established a Corrective and Preventive Action procedure to identify areas for improvement to current products and processes and to implement actions that will prevent issues from reoccurring or happening at all.
Customer Complaints
Customer complaints are communicated to the appropriate site for review and if necessary investigation. These locations have procedures that define how the complaint is investigated and, when applicable, the corrective actions implemented. The procedures define the actions necessary to accomplish field corrections or recall. In the event of a recall, affected customers will be identified and contacted.
Customer Audits
Quality audits by our customers are permitted at our facilities. We request that adequate notification be provided (30-days prior to visit) and that an agenda be sent from the customer within 2-weeks of the requested audit date(s). BerrChem reserves the right to cancel or revise the audit schedule.
Regulatory Audits
BerrChem is willing to offer full cooperation to all requests for Government or regulatory audits of our facilities.