SOP On Safety In Quality Control Laboratory OBJECTIVE: The purpose of this SOP is to lay down a procedure for describe safety aspects and precautions during working in the department. SCOPE: This SOP on Safety in Quality Control Laboratory is applicable for guidelines regarding safety hazards occurring during laboratory working and to guide on safe […]
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Out of Specification Investigation Phase II (Unknown Cause / No Assignable Cause ) & Phase III Phase II Investigation – Unknown Cause / No Assignable Cause These are difficult to perform as the result can be 1 to 2 weeks after the analysis was performed and maybe weeks after the batch was manufactured. It is
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Out Of Specification Investigation Phase II (MHRA) Conducted when the phase I investigations did not reveal an assignable laboratory error. Phase II investigations are driven by written and approved instructions against hypothesis. Prior to further testing a manufacturing investigation should be started to determine whether there was a possible manufacturing root cause. If not already
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Out Of Specification Investigation Phase Ia & Phase Ib (MHRA) Phase Ia Investigation Definition: Out of Specification Investigation Phase la investigation is to determine whether there has been a clear obvious errors due to external circumstances such as power failure or those that the analyst has detected prior to generating data such as spilling sample
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Out of Specification &Out of Trend Investigations (MHRA) Laboratory Analysis Investigations of “Out of Specification (OOS) / Out of Trend (OOT)/ Atypical results” have to be done in cases of: Batch release testing and testing of starting materials. In-Process Control testing: if data is used for batch calculations/decisions and if in a dossier and on
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SOP ON OPERATION AND CALIBRATION OF pH METER OBJECTIVE: The purpose of this Standard Operating Procedure (SOP) is to describe the procedure for Operation and Calibration of PH Meter. Make:……, Model: ……. ID No: …… SCOPE: This SOP is applicable to PH Meter in the Quality Control Department at Pharmaceutical manufacturing facility. RESPONSIBILITY:
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SOP for Safety In Quality Control Laboratory OBJECTIVE: The purpose of this SOP is to lay down a procedure to describe safety rules and precautions during working in the Quality Control department. SCOPE: This SOP is applicable for guidelines regarding safety hazards occurring during laboratory working and to guide on the safe handling of various
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What is an Active Pharmaceutical Ingredient? “active pharmaceutical ingredient (API) Any substance or combination of substances used in a finished pharmaceutical product (FPP), intended to furnish pharmacological activity or to otherwise have direct effect in the diagnosis, cure, mitigation, treatment or prevention of disease, or to have direct effect in restoring, correcting or modifying physiological
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GMP Requirements for Certificates of Analysis (CoA) At times of outsourcing and globalisation, the significance of Certificates of Analysis (CoA) is growing. Ultimately, the user of such certificates has to rely on their accuracy and completeness. There are CoAs for excipients, APIs, packaging materials and finished products. A closer look at the guidelines shows that there are
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General Safety Rules for Quality Control Laboratory. General Safety Rules For Quality Control Laboratory. General and specific safety instructions reflecting identified risk, should be made available to each staff member and supplemented regularly as appropriate (e.g. with written material, poster displays, audiovisual material and occasional seminars). General rules for safe working in accordance with national
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