SECTIONS OF THE DRUGS AND COSMETICS ACT, 1940 FOR MEDICINE ARRANGEMENT OF SECTIONS CHAPTER I INTRODUCTORY SECTIONS 1. Short title, extent and commencement. 2. Application of other laws is not barred. 3. Definitions. 3A. Construction of references to any law not in force or any functionary not in existence in the State of Jammu and…
Validation Questions Question 1: When should a company validate/ revalidate cleaning procedures? When is validation not required? Answer: Ref. Section 7.0 and 10.0 Companies should look at each situation individually and determine the needfor validation. Section 7.0 provides a basic template, which may be used as a starting point in this evaluation. The necessity to…
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Cleaning process Control To verify and qualify a cleaning process, the cleaning process needs to be unremarkable and sufficiently robust for the to-be-cleaned equipment. It would be clear which way are considered part of the product process /unit operation and which are part of the cleaning process, for Illustration if the pre-rinse or wash-out which…
PRODUCT RECALL AND MOCK RECALL PROCEDURE A product recall may be defined as the retrieval from the marketplace of a batch (es) of a medicinal product as a result of a quality defect or other issue being identified with the batch (es) which resulted in the batch (est.) not to be in compliance with the…
Objective: To lay down a procedure for the Management of Documents in the Quality Assurance Department. Scope: Applicable for Document Management system in Quality Assurance department. Responsibility: Quality Assurance Department Accountability: Manager Q.A. is accountable for the compliance of this SOP. Procedure: Storage of Documents in Record Room. Documents shall be stored in the record…
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EXPIRATION DATING AND STABILITY TESTING FOR HUMAN DRUG PRODUCTS Each drug product may be a unique article because of, for instance, differences in (1) chemical and physical properties of the active ingredients or the excipients, (2) manufacturing procedures, (3) formulations, (4) containers and closures, (5) proposed storage conditions, and (6) the stability of the article…
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DOCUMENTATION IN PHARMA Well-established documentation system exists to implement Good Documentation Practices, which is a part of Quality Assurance. Clearly written documents are prepared, reviewed and controlled, which prevents the errors from verbal communication and permits traceability for all activities carried out. Quality Assurance is responsible for the revision and distribution of documents and concerned…
SOP on Handling of Out of Specification (OOS)
PURPOSE OF PERSONAL HYGIENE: To lay down the procedure for to ensure for Personnel hygiene of all employees working in the company. SCOPE OF PERSONNEL HYGIENE: This SOP is applicable for all employees working at Pharmaceuticals Company. RESPONSIBILITY OF PERSONNEL HYGIENE Preparation of SOP: HR Executive /Officer Checking and Review of the SOPs: Manager HR…
Standard/non-standard processes The non-standard process is determined by a combination of the nature of the active substance, the nature of the finished product, the actual process itself, and the production experience of the manufacturer. All biological products are considered to be non-standard. The following categories are examples of products or processes which could be considered…
Process validation scheme Traditional process validation Where validation data on production-scale batches are not provided with the application and traditional process validation is proposed, the process validation scheme described below should be submitted by the applicant. This should outline the formal process validation studies to be conducted on production-scale batches (the number of batches used…
Process validation (Continuous process verification) for finished products Process validation can be defined as documented evidence that the process, operated within established parameters can perform effectively and reproducibly to produce a medicinal product meeting its predetermined specifications and quality attributes (ICH Q7). Continuous process verification has been introduced to cover an alternative approach to process…
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Qualified Persons A qualified person shall be in possession of a diploma, certificate, or other evidence of formal qualifications awarded on completion of a university course of study, or a course recognized as equivalent by the Member State concerned, extending over a period of at least four years of theoretical and practical study in one…
PROCEDURE FOR INVESTIGATION OF OUT OF TREND RESULTS (OOT)
SOP FOR PROCEDURE FOR OPERATION AND CALIBRATION OF STOPWATCH
Quality Management System Definition: A Quality Management System is a collection of policies, procedures, plans, resources, processes, practices, and the specification of responsibilities and authority of an organization designed to achieve product and service quality levels, customer satisfaction, and company objectives. Documentation: Quality Policy – describes the organization’s approach to quality Quality Manual – Addresses…
HAZARD ANALYSIS OF CRITICAL CONTROL POINT (HACCP) TABLE OF CONTENTS HAZARD ANALYSIS OF CRITICAL CONTROL POINT 1. Declaration. Quality Policy Quality Objectives Company Profile Layout of Plant Organization Chart HACCP Introduction HACCP Prerequisite Programs Seven Principles of HACCP Hazards HACCP Scope HACCP Team Responsibility Hazard Analysis Introduction Hazard Analysis for processing steps Hazard Analysis Worksheet…
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Meanings of terms Alcohol: The term “alcohol” without qualification means ethanol (95 percent). Other dilutions of ethanol are indicated by the term “ethanol” or “alcohol” followed by a statement of the percentage by volume of ethanol (CZH60) required. Desiccator: A tightly closed container of suitable size and design that maintains an atmosphere of low moisture content…
HACCP VALIDATION REPORT LIST OF CONTENTS S. No. CONTENTS PAGE No. 1.0 Objective 2.0 Scope 3.0 Reason for Validation 4.0 Responsibility 5.0 Procedure for Validation 6.0 Sampling Plan 7.0 Data Recording 8.0 Acceptance Criteria 9.0 Deviations 10.0 Conclusion and Recommendation OBJECTIVE: HACCP validation is the element of verification focused on collecting and evaluating the hazards…
Interview Questions & Answers (Quality Assurance) 1.What is Quality Assurance : Quality Assurance is a deep concept covering all matters that individually or collectively influence the quality of a product. It is the complete & whole of the arrangements made with the object of ensuring that the manufactured products are of the quality required for their…
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