Pharmaguideline
Pharmaguideline provides all pharmaceutical regulatory guidelines including quality control, quality assurance, microbiology, and production departments. Get all SOPs of these all departments. Calibration and operating procedures of all quality control instruments and operating procedures of all production equipment are also provided on the website. All GMP topics are also covered for quality assurance.
- Website
- pharmaguideline.com · all feeds from this site
- Feed URL
https://www.pharmaguideline.com/feeds/posts/default?alt=rss
Read it in your FeedListing reader
Or add to: Feedly Inoreader Raw feed
Latest posts
-
Measuring Validation Effectiveness in Pharma GMP
Validation can be considered successful only when it presents dependable proofs that a process, equipment, utility, analytical technique, or IT system is under control during its entire lifetime and can fulfill its intended function. Therefore, assessment of the productivity of…
-
Risk Assessment Tools Used in Pharmaceutical Validation
Risk assessment plays a crucial role in pharmaceutical validation as it enables the ascertainment of different process stages, machinery processes, systems, and qualities that require the most attention. The tools used for validation risk analysis available in pharmaceutical…
-
Risk-Based Validation in the Pharmaceutical Industry
Risk-Based Validation refers to the process of organizing validation activities of pharmaceutical process, system or method based on the actual risks for product quality, patient safety and data integrity. It assumes that scientific knowledge and quality risk management (QRM)…
-
Validation Audit Checklist for Pharmaceutical GMP
Validation audit evaluates a pharmaceutical site's validation process to determine if the validation program is scientifically acceptable, appropriately documented and implemented in accordance with authorized processes and remains throughout the lifecycle of equipment,…
-
Process Validation Failure Investigation and Root Cause
Process validation failure takes place when a process does not satisfy the requirements established beforehand for design validation and does not show stable process performance or sufficient supporting evidence for validation. The investigation of the process validation failure…
-
Cleaning Validation Microbial Limits and Acceptance Criteria
Microbial acceptance criteria for cleaning validation are used to show that the cleaning process provides the required level of control over microbial contamination for the intended use of the equipment. A single universal microbial limit is not a valid approach to all…
-
Cleaning Validation Recovery Study | Swab and Rinse
A cleaning validation recovery study is used to determine the effectiveness of a specified sampling technique in collecting residues from pharmaceutical equipment and rendering them available for analysis. A cleaning validation recovery study will assess the efficiency of…
-
Clean Hold Time Study in Pharmaceutical Manufacturing
A Clean Hold Time Study (CHT) determines how long cleaned equipment can stay clean and unused. Establishing the clean hold time is an integral part of cleaning validation as it identifies the necessary storage conditions plus the kind of protection from contamination that is…
-
Cleaning Validation Acceptance Criteria | Setting Limits
Cleaning validation acceptance criteria state the maximum allowed levels of product residues, cleaning agents and other relevant contaminants left on pharmaceutical production equipment after its cleanliness, in order to scientifically justify, quantify and sustain these limits…
-
Validation Data Review | What QA Must Check
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…
-
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…
-
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…
-
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…
-
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…
-
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…
-
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…
-
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…
-
Validation Periodic Review | Maintaining the Validated State
The validation process does not guarantee the continued qualification of pharmaceutical equipment, systems, cleaning methods, or processes. Change in conditions of manufacture, modifications of equipment, occurrences of deviations, emergence of analytical trends and newly…
-
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…
-
Common Sterilization Validation Audit Findings
It is expected that sterilization validation will show that a particular sterilization process will be able to ensure the sterility in its intended manner and thus will ensure that the product, its package and container would not be subjected to prohibited influence.…