The validation data review is the process of critically analyzing the data generated during validation or qualification studies with the objective of checking whether the study was conducted according to the protocol, whether the data obtained is valid, whether the acceptance criteria were realized and whether the conclusions are based on scientific understanding. In addition to simply summarizin…
Showing posts with label Quality Assurance. Show all posts
Dirty Hold Time Study in Cleaning Validation
A Dirty Hold Time Study during the cleaning validation process calculates the longest period of time manufacturing equipment can stay dirty after the production of a product before the established cleaning process begins. It establishes whether residues will be able to be removed after being subjected to a specified holding condition and if any delays produce any extra chemicals or microbiologica…
Validation Deviations | Classification and Investigation
A validation deviation is defined as any non-conformance that occurs during any validation or qualification process in relation to the validation protocol that has been previously approved, prescribed acceptance criteria, procedure that has been approved and anticipated conditions. Any validation deviations should be recorded, investigated, classified according to their importance and assessed in…
Validation Responsibilities of Pharmaceutical Departments
Validation in the pharmaceutical industry involves multiple departments working together. Quality Assurance (QA), Quality Control (QC), Production and Engineering all add their own knowledge to ensure the validation of processes, instruments, services, tests, etc. The responsibilities for validation must be laid out in the standard operating procedure, description of the validation process and re…
Validation Report Review and Approval in GMP
A validation report review is performed to verify if an accomplished validation investigation was executed as per its sanctioned protocol, produced good quality evidence, implemented remediation and satisfied previously set acceptance criteria. Validation report endorsement is the official conclusion that documented data are valid and permissible according to the pharmaceutical quality assurance …
Validation Strategy in Pharmaceutical Manufacturing
A validation strategy refers to the methodology employed in the pharmaceutical industry to validate that their equipment, processes, utilities and cleaning methods are appropriate for certain purposes and under control during their entire life span. It answers such questions as what will be validated and why, what evidence is required, what guidelines and principles will be followed, etc.
Types of Validation in Pharmaceutical Industry
Validation shows that a pharmaceutical process, method, system, facility, or equipment can operate consistently. Validation can mean various things depending on the article that is validated, where it is within its lifecycle, what the company knows about the process, and what its regulatory strategy is.
Validation Sampling Strategy for Pharmaceutical Manufacturing
A Validation Sampling Strategy describes what will be sampled, where samples will come from, how many samples will be taken, when sampling will occur and how the data collected will provide evidence of process control. In pharmaceutical validation, sampling is more than a laboratory testing process – it is part of the scientific evidence for the successful completion of a process.
Validation Effectiveness | Keeping the Validated State
The efficacy of validation denotes the extent to which an approved process, system, method, equipment, or cleaning practice – that has already been validated – continues to produce intended results on a regular basis. To show that a process is effective within the context of pharmaceutical manufacturing, one needs to have objective proof that the method does produce the required satisfactory resu…
Critical Quality Attributes (CQAs) for GMP Process Control
The term critical quality attributes (CQAs) refers to the objectives established for some of the relevant physical, chemical, biological, or microbiological properties of a drug substance, which must be within appropriate limits or ranges in order for the products to acquire quality.
Regulatory Actions in the Pharmaceutical Industry
The occurrence of regulatory action is one of the most severe consequences that can befall a pharmaceutical company as a result of a regulatory agency discovering serious issues with its production, quality, data integrity, or compliance systems.
HACCP in Pharmaceutical Manufacturing | A Practical Guide
Hazard Analysis and Critical Control Point, commonly known as HACCP, is a systematic preventive technique for identifying hazards and assuring that they are controlled before they threaten product quality. HACCP was developed for food production but the principles can be equally effective when applied in pharmaceutical manufacturing as part of the Pharmaceutical Quality System.
Periodic Review in Pharmaceutical GMP Systems
The periodic review is an essential part of a suitable Pharmaceutical Quality System. It allows examining the ongoing processes and understanding if a process, equipment, system, document or validated system still performs according to the requirements.
Pharmaceutical Document Management System Guide
A vast volume of highly regulated data is produced by a drug-producing company on a daily basis. Various documents, such as Standard Operating Procedures (SOPs), specifications, protocols, documents, forms, policies and log books must be maintained in a precise and timely manner ensuring their availability at all times.
Documentation Gaps in Pharmaceutical GMP Systems
Documentation refers to the records of various events throughout the process of pharmaceutical manufacturing. In reality, however, this term is much broader. Properly organized documentation system enables a company to recreate any operations, monitor who performed a specific operation, trace ways of how this operation had been accomplished and assess if and how this operation was done in a valid…
Effective Validation in Pharmaceutical Manufacturing
Validation can be defined as written proof showing that a process system or equipment is working as it was meant to be. In reality, however, successful validation is much more complicated than simply going through the protocol steps and obtaining signatures.
Training Records Management in Pharmaceuticals
At any pharmaceutical production facility, training records serve as proof that an employee has attended a training program. It supports the quality system by showing that the workforce is properly qualified to perform their responsibilities.
Validation of Continuous Manufacturing Processes
Continuous manufacturing affects the way processes are developed, certified and validated in the pharmaceutical industry. Instead of manufacturing pharmaceutical products in batches, which means a fixed amount of material produced until it is stopped, continuous manufacturing refers to uninterrupted or semi-constant processing of materials through the interconnected processes involved in the manu…
Failure Mode and Effects Analysis (FMEA) in Pharmaceuticals
The pharmaceutical industry operates on the preventative principle of failures, which means production failures are avoided before they occur and have an impact on product quality or patient safety. While analyzing deviations, complaints and investigations can provide much needed lessons once the event has already taken place, the best quality systems work on the principle of predicting risks and…
Validation Report in Pharmaceuticals: A Practical Guide
Validation tests do not finish once the testing phase has been accomplished. A good validation report proves the outcome of the validation process and contains information about what was tested, the method applied for conducting tests, the results obtained and difficulties faced during the tests. The validation report provides written evidence that a facility, a system, equipment, utility, proces…
