trackwise trackwise software what is trackwise sparta trackwise what is track wise and what is use of track wise in the pharmaceutical industry? Track wise is software widely used in the pharmaceutical industry for quality management and regulatory compliance purpose. Quality management includes deviations, CAPA that is corrective and preventive actions, change controls, market … Read more
what is USFDA & market complaint in pharmaceutical industry Q.1 Why USFDA auait is important in pharmaceutical industry ? 1. Reg ulatory Compliance: USFDA audit compliance ensures adherence to strict regulations for public health and medication safety. 2. Market Access: Clearance of USFDA audit provides entry to the profitable US pharmaceutical market. 3. Reputation … Read more
What is MHRA Full form? Medical and Healthcare Products regulatory agency is UK regulatory authority for medicine and medical device. Which country does MHRA regulate? MHRA Regulate medicine and medical device in UK i.e. wales, northern irland ,england scotland. What is the frequency of MHRA Audit? Frequency of MMHRA Audit is 2 to 3 years … Read more
SOP for vendor audit OBJECTIVE:To define the procedure for vendor approval and qualification of vendor. SCOPE:This SOP applies for procedure of vendor approval to all incoming raw materials and packaging material. This SOP also applies to qualify vendor, approved vendor list. REFERENCE:Inhouse RESPONSIBILITY: QA Incharge/QA officer: To conduct vendor … Read more
SOP for daily GMP checks OBJECTIVE: To provide Guidelines for Daily GMP Checks. SCOPE:1. This SOP provides guidelines regarding procedure for daily GMP checks to be performed by QA thrice a day (i.e. initial, middle & at the end of shift). 2.Daily GMP checks are important for maintaining & improving quality of product … Read more
Sop for internal audit OBJECTIVE:To enumerate the guidelines to be considered for conducting an internal Audit. It is carried out for self assessment and thereby improving the quality and standard of the products. SCOPE:This SOP describes the guidelines for conducting internal audits of various departments. REFERENCE: NA RESPONSIBILITY:Quality systems manager/QA … Read more
Good documentation practices Objective:To provide procedure for good documentation practices during filling report. SCOPE:This SOP applicable to QC,Engineering,proudction and HR department in the company. This SOP minimizes the document error in the company. REFERENCE: In House RESPONSIBILITY: All employees avoiding the mistake or error while filling the documents. ABBREVATION: QC … Read more
SOP:procedure for Issuance of Log Books. OBJECTIVE: This SOP is to define the procedure for Issuance of Log Books to various departments. SCOPE: This procedure is applicable for all Log Books to be used by various departments for various purpose. REFERENCE: In-house RESPONSIBILITY: Department head/Executive- To demand for log book QA personnel- To … Read more
SOP FOR GOOD DOCUMENT PRACTICES (GDP) Objectives of this SOP are listed below – Define the system of information and control. To minimize the risk of misinterpretation and errors inherent in oral or casual written To provide unambiguous procedures to be followed. To provide confirmation of performance of a task. To allow calculations to … Read more
SOP FOR non conformance reporting. OBJECTIVE: To lay down a procedure for non conformance reporting. SCOPE: This SOP shall be applicable for non conformance reporting to department head. REFERENCE: In-house RESPONSIBILITY: Concerned Department Personnel: To report the non conformance as per SOP. QA Personnel: To investigate the non conformance in conjugation with concerned department … Read more
