Pharmaceutical Guidelines

Aurobindo Pharmaceutical USFDA Warning Letter- 2022

Aurobindo Pharmaceutical Limited MARCS-CMS 618091 — JANUARY 12, 2022 January 12, 2022 WARNING LETTER Delivery Method:VIA UPSProduct:Drugs Recipient: Mr. Narayanan GovindarajanAurobindo Pharmaceutical Limited Floor No.’s 22, 23 & 24 Galaxy Plot No-1, Survey No: 83/1, Hyderabad Knowledge City Raidurg Panmaktha, Ranga Reddy District Hyderabad500081 Telangana IndiaIssuing Office:Center for Drug Evaluation and Research | CDER United States Warning Letter 320-22-10 January …

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Warning Letter of Lupin Limited 2022

FDA Warning Letter

Lupin Limited MARCS-CMS 633703 — SEPTEMBER 27, 2022 September 27, 2022 WARNING LETTER Delivery Method:Via EmailProduct:Drugs Recipient: Site Head and Senior General Manager ManufacturingLupin Limited T-142, MIDC Tarapur via Boisar Palghar 401506Maharashtra IndiaIssuing Office:Center for Drug Evaluation and Research | CDER United States Warning Letter 320-22-25 September 27, 2022 Dear Mr. Patel: The U.S. Food and Drug Administration (FDA) …

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Biological Indicator For Heat Sterilisation

Microbiology Study

1 PARAMETERS OF BIOLOGICAL INDICATORS FOR HEAT STERILISATION 1-1 z-Value Sterilisation processes can be operated at temperatures lower than the standard 121 °C (for longer exposure times) or at higher temperatures (for shorter exposure times). The z-value (the temperature difference that leads to a 10-fold change in the D-value of the biological indicator) is used to compare the efficacy …

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Method of Sterilisation – Dry Heat Sterilisation

Ph. Eur. General Chapters

Principle Dry heat sterilisation is a terminal sterilisation method based on the transfer of heat to the articles to be sterilised. Heat may be transferred by means of convection, radiation or direct transfer. Equipment Dry heat sterilisation is carried out in an oven with forced air circulation or using other equipment specifically designed for this …

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General Introductions of Methods of Sterilisation As per Ph. Eur. General Chapters 5.1.1 Part -2

Ph. Eur. General Chapters

Sterilisation may be carried out by one of the methods described hereafter. Modifications to, or combinations of, these methods may be used, provided that the chosen procedure is validated with respect both to its effectiveness and to the integrity of the product including its container. For all sterilisation methods, the critical parameters of the procedure …

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General Introductions of Methods of Sterilisation As per Ph. Eur. General Chapters 5.1.1

Ph. Eur. General Chapters

Sterility is the absence of viable micro-organisms, as defined by a sterility assurance level equal to or less than 10– 6. Sterility is a critical quality attribute for a wide variety of human and veterinary preparations, including but not restricted to: — preparations required to be sterile due to their route of administration, such as parenteral, ophthalmic …

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Data Integrity Problems as Main Topic of FDA Warning Letter

FDA Warning Letter

Data integrity continues to be one of the main topics during FDA inspections. One of the contributing causes for the warning letter to the American company Vi-Jon was the lack of controls to ensure the integrity of electronic data as well as insufficient access control to IT systems. Based on an inspection which was carried …

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SOP For Handling of Reprocessing, Reworking and Recovery

Quality Assurance

OBJECTIVE: The purpose of this SOP is to lay down a procedure for reprocessing, reworking and recovery of the drug products. SCOPE: This SOP is applicable for handling of reprocessing, reworking and recovery of the drug products, at different stages of manufacturing, at the manufacturing facility. RESPONSIBILITY: Authorized Designee of Quality Assurance shall …

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SOP For Calibration

Quality Assurance

OBJECTIVE To define the general requirements for an effective calibration control system to ensure that applicable measuring and test equipment is calibrated and maintained within accuracy limits sufficient for their intended purpose. SCOPE This procedure is applicable for calibration of all equipment /instrument/ measuring devices. RESPONSIBILITY Follow up: Concern Department Officer/Executive Overall responsibility: Concern …

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SOP for Handling of Artwork

Quality Assurance

OBJECTIVE: The objective of this SOP is to lay down a procedure for preparation, approval, distribution, revision, retrieval and destruction of artwork. SCOPE: This SOP is applicable for preparation, approval, distribution, revision, retrieval and destruction of artwork at the manufacturing facility. RESPONSIBILITY: Marketing: Responsible for Color and Design Production Department: Responsible for mentioning size as …

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