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.
Showing posts with label Audit. Show all posts
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…
Working Culture in USFDA Approved Pharmaceutical Plants
A USFDA approved pharmaceutical plant is not simply a manufacturing location that has passed an inspection; it is a facility that has quality, compliance and safety built into its daily operations as an organization (as opposed to a facility that uses validated systems, equipment and high tech equipment) to provide best in class products with minimal defects.
FDA Forms Generally Used in Pharmaceutical Inspection
Regulatory inspections are a fundamental part of the pharmaceutical manufacturing process. They allow a company to verify compliance with Current Good Manufacturing Practice (cGMP) requirements and any related regulatory requirements. Investigators from the Food and Drug Administration (FDA) document the inspection activities, observations, evidence collected and regulatory actions using various …
GMP Violations at Indian Pharmaceutical Facilities | Key Insights
GMP violations are found in some pharmaceutical manufacturing facilities in India. These GMP violations mean these manufacturers do not follow the good manufacturing practices regulations and this may cause serious health problems to the patient consuming the drug products manufactured in these facilities.
Preparing for FDA Inspections | Best Practices for Compliance
The pharmaceutical business relies heavily on inspections from a drug manufacturer’s regulatory authority, but none have the level of scrutiny from the U.S. Food and Drug Administration than any other global regulatory authority. Manufacturers that manufacture drugs must always be prepared for a routine inspection or an audit before their product can get market approval, the FDA requires that man…
Are You Ready for an FDA Inspection? Complete Inspection Guide
As part of their work, pharmaceutical companies must have their products inspected for safety and efficacy, as well as that all manufacturing meets certain regulatory standards. Of all the regulatory agencies in different countries, the Food & Drug Administration (FDA) in the United States has some of the highest standards. A successful inspection can have a major impact on a pharmaceutical c…
Impact of Culture and Behaviors on Data Integrity Compliance in Pharmaceuticals
Pharmaceutical quality systems rely heavily on data integrity as a fundamental element. The accuracy, reliability, and completeness of data are mandatory requirements under regulatory expectations and will impact the safety of patients, the quality of product(s), and the reputation of the pharmaceutical industry as a whole.
Impact of Training Management on Quality Issues in Pharmaceuticals
Patient safety is the result of controlling product quality in the pharmaceutical industry. The quality of each product is affected not only by advanced equipment, validated processes and strict regulatory controls but also by one consistent factor that drives quality outcomes for all pharma operations: Training Management.
What to Inspect During Self-Inspection in Pharmaceutical Companies
The Good Manufacturing Practices (GMP) framework includes self-inspections as a crucial part of ensuring companies involved in the manufacture and sale of drugs abide by both regulatory requirements and provide consistently good quality products.
Allergen Control Plan for Pharmaceuticals and Controls
Allergic reactions are not restricted to food manufacturing alone; however, there is also a rising concern about allergens in the pharmaceutical sector too. Trace amounts of allergens from different sources will cause very serious allergic responses from a small number of sensitive individuals (e.g., certain tree nuts). Therefore, increased scrutiny by FDA/EMA means that there need to be procedur…
FDA 483 Observations Related to Cleaning in Pharma
Cleaning in pharmaceutical production is not only a standard procedure, it is also a regulatory requirement that enhances both product safety and quality. When cleaning is insufficient, the risk of contamination, cross-contamination or contaminated products can result in the distribution of dangerous drugs.
Improving Quality Through Supplier Audits in Pharma
The pharmaceutical industry establishes product quality from the time raw materials, components and services are provided to the manufacturer by their suppliers. A weakened link in the supply chain will therefore have the potential to negatively impact product safety, regulatory compliance and patient trust.
