Month: February 2019

GMP Requirements for Certificates of Analysis (CoA)

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 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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Quality Control Testing of Raw Materials, APIs, and Finished Products.

Quality Control Testing of Raw Materials, APIs, and Finished Products. The Quality Control Testing  of Raw Materials, APIs, and Finished Products sample should be tested in accordance with the work plan of the laboratory after completion of the preliminary procedures. If this is not feasible the reasons should be noted, e.g. in the analytical worksheet, …

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SOP For Good Microbiological Laboratory Practice

SOP For Good Microbiological Laboratory Practice. Objective:- The Purpose of SOP For Good Microbiological Laboratory Practice to lay out the procedure of Good Microbiological Laboratory Practice in Non- Sterile  Pharmaceutical Products manufacturing plant. Scope:- This SOP is applicable for Good Microbiological Laboratory Practice in the Microbiology Laboratory at Non- Sterile  Pharmaceutical Products manufacturing plant. Responsibility:- …

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Guidelines on Packaging for Pharmaceutical Products

Guidelines on Packaging for Pharmaceutical Products All medicinal products need to be protected and “consequently need to be packaged in containers that conform to prescribed standards, particularly with respect to the exclusion of moisture and light and the prevention of leaching of extractable substances into the contents and of chemical interaction with the contents. However, …

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Common Terms & Definitions used in Qualification & Validation of Heating, Ventilation and Air-Conditioning Systems for Non-Sterile Pharmaceutical Dosage forms.

Common Terms & Definitions used in Qualification & Validation of Heating, Ventilation and Air-Conditioning Systems For Non-Sterile Pharmaceutical Dosage Forms.   Design parameters should be set realistically for each project, with a view to creating a cost-effective design, yet still complying with all regulatory standards and ensuring that product quality and safety are not compromised. …

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Principles of Cleaning Validation

Principles of Cleaning Validation Cleaning validation should be performed in order to confirm the effectiveness of any cleaning procedure for all product contact equipment. Simulating agents may be used with appropriate scientific justification. Where similar types of equipment are grouped together, a justification of the specific equipment selected for cleaning validation is expected. A visual …

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Qualification Stages For Equipment, Facilities, Utilities And System.

Qualification  Steps For Equipment, Facilities, Utilities And System. Qualification activities should consider all stages from initial development of the user requirements specification through to the end of use of the equipment, facility, utility or system. The main stages and some suggested criteria (although this depends on individual project circumstances and may be different) which could …

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SOP For Risk Management

SOP For Risk Management. Objective :- The purpose of this SOP is to lay out the procedure for Risk Management (risk identification, analysis, evaluation, reduction / mitigation, communication and conclusion of risk in order to ensure the quality, safety, integrity and purity of the drug product by using FMEA (Failure Mode Effect Analysis). Scope:-  The …

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