SOP ON INVESTIGATIONS
SOP ON INVESTIGATIONS Investigation – A documented logical and/or scientific review of data related to all quality events that leads to the identification of the root cause and corrective and preventive action
Category: Quality Assurance
HANDLING AND MANAGEMENT OF PRODUCT COMPLAINT
HANDLING AND MANAGEMENT OF PRODUCT COMPLAINT PRODUCT Complaint: A market/consumer complaint is a notification that a product is in commercial distribution (which also includes a physician sample), May be in violation of the laws or regulations administered by the FDA (Drug Control Authority), May have caused an illness, injury or death, Is alleged to have…
QUALITY BY DESIGN AND SCALE – UP
QUALITY BY DESIGN AND SCALE – UP Unit operations are the individual basic steps in a process that when linked together define the process train and result in the final product. In practice, a unit operation is defined as an individual step that is carried out on one piece of equipment. In biopharmaceutical API unit…
Retrospective Validation
Retrospective Validation The retrospective validation – to establish manufacturing procedures for products that are considered stable and resource limitations, prospective validation programs cannot be possible. Before initiation of retrospective validation, the numerical in-process and end-product test data of historic production batches are considered for statistical analysis, and the equipment, facilities, and subsystems used in connection…
Quality Excellence & Quality Culture Check
Quality Excellence & Quality Culture Check Addressing the sources of variability and defects is critically important when the failure rate is excessive or warranty obligations hurt profitability. The Quality Excellence Program helps business leaders, quality managers, and functional specialists to systematically improve process capability and consistently meet customer requirements at the lowest non-performance cost. Quality is defined by…
ANNUAL PRODUCT QUALITY REVIEW (APQR)/ PRODUCT QUALITY REVIEW (PQR)
ANNUAL PRODUCT QUALITY REVIEW (APQR)/ PRODUCT QUALITY REVIEW (PQR) This Annual product Quality review should be conducted with the objective of verifying the repeatability of existing processes, the appropriateness of current specifications for raw materials and finished products, identifying any trends and identifying any improvements to products and processes. It helps establish preventive measures, and…
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Quality inspection (Self-inspections & Benefits of Self Inspection)
Quality inspection (Self-inspections & Benefits of Self Inspection) Principle Importance and Benefits of Self Inspection What is needed Scope How can self-inspection be conducted Inspection Techniques Example of Self-Inspection Plan Who should be involved Self-inspection report Points to consider when performing self-inspection Stages of Self-Inspection Advantages & Disadvantages of Checklist Principle Self-inspections shall be conducted…
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TRAINING PROGRAMME AND MANAGEMENT
TRAINING PROGRAMME AND MANAGEMENT Training: A process that involves the acquisition of knowledge, skills, concepts, rules, procedures, processes, etc. Thus, personnel remain competent to perform the task(s) assigned.
REGULATORY IMPACT ON OOS
REGULATORY IMPACT ON OOS Stability study required OOS should be reported to RA OOS batch should not be sold to the Regulatory market OOS batch can not be blended with a fresh approved batch OOS batch can not be directly sold to the market Reporting Test Result Result: Averaging Appropriate Inappropriate Outlier Reporting Interpretation of…
OOS RECORDING PROCEDURE
OOS RECORDING PROCEDURE REPORTING TO THE LABORATORY SUPERVISOR RECORDING AND NUMBERING OF OOS INVESTIGATION BY ANALYST LABORATORY TESTING APPROVAL BY LAB. SUPERVISOR TESTING BY ANALYST PROCEDURE OF OOS INVESTIGATION: A written record of the review should include the following information A clear statement of the reason for the investigation. A summary of the aspects of…
SECONDARY WORKING STANDARDS
REGULATORY RECOGNITION OF SECONDARY WORKING STANDARDS (1) Human Drug CGMP Notes, Vol 9, Number 3, 2001 (Internal FDA Publication): Q: Can a company use reference standards from sources other than the USP? A: Yes. Using a source other than USP can be acceptable provided the reference standard incorporates the critical characteristic properties, is suitable for…
Process validation protocol
Process validation protocol A written plan stating how validation will be conducted, including test parameters, product characteristics, production and packaging equipment, and decision points on what constitutes acceptable test results. The process validation protocol is defined as the experimental plan that design thoroughly the validation programmed. Protocol of the Process validation consists of the following…
PROCEDURE FOR ROUNDING OFF NUMERICAL VALUES AND REPORTING SYSTEM
PROCEDURE FOR ROUNDING OFF NUMERICAL VALUES AND REPORTING SYSTEM
Hold Time Study Protocol
Hold Time Study Protocol 1. Objective \ Scope 1.1. Hold time study data shall give the assurance of the maximum allowable hold times for bulk and in-process drug products. Generally, one lot can be used for validating hold times if any inconsistency results were observed then another two lots can be used for this study….
CRITICAL AND MAJOR DEFICIENCIES
CRITICAL AND MAJOR DEFICIENCIES Compliance and enforcement measures are dependent upon a number of factors, including the significance of violations such as a “Critical” deficiency and a large number of “Major” deficiencies, the history of the site, potential risks to products, and assessment of the manufacturer’s proposed corrective actions. Where appropriate, this may include an…
GMP Deficiencies in Pharmaceutical Industry “Critical and Major deficiencies”
GMP Deficiencies in Pharmaceutical Industry “Critical and Major deficiencies” The GMP Deficiencies findings of a Good Manufacturing Practice (GMP) inspection can have a substantial impact on both your organization and, subsequently, public health. If the GMP Deficiencies found are classified as significant, they may necessitate cessation of manufacturing activities and/or product withdrawal from the market. In the advent of…
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INSPECTIONS/AUDITS
INSPECTIONS/AUDITS 1. Manufacturing Process i. Drug Product (Dosage Form) In many cases, clinical production or trial runs of a new drug are produced in facilities other than the ones used for full-scale production. The facilities and controls used for the manufacture of the batch or batches are audited. For a generic drug product, the biobatch…
ELECTRONIC RECORDS
ELECTRONIC RECORDS Scope (a) The regulations in this part set forth the criteria under which the agency considers electronic records, electronic signatures, and handwritten signatures executed to electronic records to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper. (b) This part applies to records in electronic form that…
RESOURCES-THE QUALITY SYSTEMS MODEL
RESOURCES-THE QUALITY SYSTEMS MODEL Appropriate allocation of resources is key to creating a robust quality system and complying with the CGMP regulations. This section discusses the role of resources in developing, implementing, and managing a robust quality system that complies with CGMP regulations. 1. General Arrangements Under a robust quality system, sufficient resources should be…
MANUFACTURING-THE QUALITY SYSTEMS MODEL
MANUFACTURING-THE QUALITY SYSTEMS MODEL Significant overlap exists between the elements of a quality system and the CGMP regulation requirements for manufacturing operations. It is important to emphasize again that FDA’s enforcement programs and inspectional coverage remain based on the CGMP regulations. When quality system elements in this section do not correlate to the CGMP regulations,…