The classification of sterile areas indicates how clean the surrounding area must be with regard to the condition of the environment in question in pharmaceutical manufacturing. The concept of sterile area classification also includes regulation of airborne contaminants in sterile processes, where the risk of getting microorganisms is eliminated.
Showing posts with label Regulatory. Show all posts
GMP Compliance Failures | Major Risks and Root Causes
The occurrence of failures in GMP compliance is often linked to a contribution of multiple weak links rather than being a result of a single occurrence of an error or violation in procedures or SOPs. Rather severe GMP compliance problems normally indicate the presence of deficiencies related to pharmaceutical quality system, defects in management supervision, weaknesses with investigation, data i…
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.
Mock Inspections in Pharmaceutical Manufacturing
It is rare for a regulatory inspection to be problematic because one of the inspectors may ask a surprise question. Problems are usually caused by the fact that the organization does not know how to demonstrate the actual actuality of its operations.
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.
Regulatory Observations in Pharmaceutical Manufacturing
When regulatory authorities make observations, it signals an indication that the company's systems, processes and controls may not comply with regulatory standards. Observations do not imply necessarily that the company's products are flawed or that quality systems have failed in their entirety. Nonetheless, observations reflect concerns raised by the regulatory authorities that necessita…
Validation Strategy for Contract Manufactured Products
The decision to outsource pharmaceutical manufacturing is an important aspect in the operations of many businesses. Contract Manufacturing Organizations (CMOs) offer extra advantages, such as manufacturing capacity and technological capabilities and allow Marketing Authorization Holders (MAHs) to concentrate on development and commercialization. Nevertheless, it is crucial to keep in mind that re…
Validation Failure Due to Poor Risk Assessment: Case Study
Validation failures are usually due to improper testing, equipment failure, or mistakes made by the operator. One of the most common causes of validation failures is not mentioned often enough, which is the poor risk assessment done in the planning phase. Inadequate identification and assessment of potential risks can lead to improper validation protocols, which could mean that critical parameter…
Documentation Practices That Impress Inspectors
During an inspection by regulatory authorities, various documentation reveal the working of a pharmaceutical facility. Although inspectors spend only few hours on the production site, they spend days scrutinizing batch reports, logbooks, evaluation documents and quality assurance documents. This documentation indicate whether processes have been implemented correctly and scientific rationale of d…
Inspection Readiness Timeline for GMP Inspections
An inspection carried out according to regulations is one of the major moments in the life of a pharmaceutical production plant. Regardless of whether the inspection is done by FDA, EMA, WHO, MHRA or any other agency, the inspectors will demand a proof that the factory has been working in the compliance mode. They will not be impressed with an industrial facility that has been tidied up and organ…
How to Perform a Mock Audit to Simulate a Regulatory Inspection
Each pharmaceutical producer hopes to successfully emerge from a regulatory inspection, which is not possible just because it wishes to do so. Food and Drug Administration (FDA) inspections, as well as other regulators like MHRA, EMA, WHO are scheduled as surprise or unnotified inspections, which quickly spot shortcomings missed by normal internal audits. The difference between a successful inspe…
Validation Policy in Pharmaceuticals | Purpose, Scope and Benefits
Validation is one of the main aspects of pharmaceutical quality assurance. It establishes documented proof that facilities, utilities, equipment, processes, cleaning procedures, analytical methods and computerized systems operate in the required way. Validation policies prescribe how the validation process will be managed in the facility while validation reports are applicable to particular syste…
Common Audit Findings in Analytical Method Validation
Analytical method validation establishes documentation for how an analytical test procedure is adequate for meeting its intended use. When the test will be performed for assays, impurities, dissolution, residual solvents, microbiology, or cleaning validation samples, the reliability of the method will directly impact the quality determination regarding the product. Once a method has been validate…
Cleaning Validation Failures and Their Root Causes in Pharmaceuticals
Validation of cleaning processes is an essential function in the pharmaceutical industry by providing documented proof that manufacturing equipment can be cleaned consistently to acceptable limits. Properly validating cleaning processes helps to avoid problems like contaminating one product with another product, carrying over active ingredients, having microbes on in-process materials, detergent …
Common FDA 483 Observations Related to Process Validation
The validation of processes is one of the major cornerstones of manufacturing in the pharmaceutical industry. The process of Validation provides a documented record that demonstrates a manufacturing process is capable of producing products that consistently meet predetermined quality attributes as well as regulatory criteria. Since valid processes can impact product quality, as well as patient…
