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 […]
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
General Introductions of Methods of Sterilisation As per Ph. Eur. General Chapters 5.1.1 Read More »
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
Data Integrity Problems as Main Topic of FDA Warning Letter Read More »
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
SOP For Handling of Reprocessing, Reworking and Recovery Read More »
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
SOP For Calibration Read More »
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
SOP for Handling of Artwork Read More »
OBJECTIVE : The purpose of this SOP is to lay down the procedure for ( Failure Investigation ) investigation failure of any activity to meet its predetermined specification, limits or acceptance criteria SCOPE : This SOP is applicable to process failures as well as non process failures (e.g. operator related). This SOP is not applicable
SOP For Failure Investigation Read More »
OBJECTIVE: The purpose of this SOP is to lay down the procedure for men and material movement. SCOPE: This SOP is applicable for material movement across the different blocks and area and men movement in miscellaneous areas at the manufacturing facility. RESPONSIBILITY: Each individual entering into the area shall be responsible to follow the practice.
SOP For Men and Material Movement Read More »
1.0 OBJECTIVE To lay down the procedure for the visual inspection and statistical evaluation of a batch ( Acceptance Quality Level). SCOPE This procedure is applicable for the visual inspection and statistical evaluation of a batch during different manufacturing stages i.e. compression, encapsulation, coating and packing in the company (XXX Name of the company).
SOP For Acceptance Quality Level Read More »
