Pharmaceutical Guidance Complete Pharma Solution

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SPECIFICATIONS: TEST PROCEDURES AND ACCEPTANCE CRITERIA AS PER ICH Q6 A GUIDELINE Question – 1: The objective of the ICH Q6 A Guideline? Answer: ICH Q6 A Guideline is intended to assist in the establishment of a single set of global specifications for new drug substances and new drug products. …

Diphenhydramine HCL is Best cough medicine without dextromethorphan for treatment of  sneezing, runny nose, watery eyes, hives, skin rash, itching, and other cold or allergy symptoms. Why Diphenhydramine HCL is used? Diphenhydramine is an antihistamine that reduces the effects of natural chemical histamine in the body. Histamine can produce symptoms …

Validation QuestionsQuestion 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 …

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 …

 Functioning, cleaning and maintenance of Static Pass Box. Objective: To lay down the method for the ordinary operation, cleansing and preservation of the Static Pass Box (SPB). Scope: This SOP is relevant to the Static Pass Box present inside the microbiology lab. Responsibility: Chemist or above of QC laboratory. Head …

Batch Manufacturing Record(BMR) Document No Effective Date Revision No Supersedes Doc No BMR November Product Name Atorvastatin  calcium equivalent to Atorvastatin 10 mg page 1 to…. Batch No Batch Size 2000000 tablets   Product Code Composition Each film coated tablet contain Atorvastatin  calcium equivalent to Atorvastatin 10 mg MFG DATE …

STERILITY ASSURANCE 〈1211〉 INTRODUCTION Definition of sterility – An item is deemed sterile only when it contains no viable microorganisms. However, this textual definition cannot be applied to actual items labeled as sterile because of irresolvable limitations in testing. Sterility cannot be demonstrated without the destructive testing of every sterile unit. …

Functioning, cleansing and maintenance of Dynamic Pass Box Objective: To lay down the method for the habitual operation, cleansing and renovation of the Dynamic Pass Box (DPB). Scope: This SOP is relevant to the Dynamic Pass Box present inside the microbiology lab Responsibility: Chemist or above of QC laboratory. Head …

 Functioning, cleansing and maintenance of Sterile Garment Cabinet Objective: To lay down the system for the ordinary operation, cleansing and protection of the Sterile Garment Cabinet (SGC). Scope: This SOP is relevant operation cleansing and protection of the Sterile Garment Cabinet present in the microbiology lab. Responsibility: Chemist or above …

Functioning , Calibration, Cleaning and Maintenance of LAF Objective: Technique for functioning, Calibration, Cleaning and Maintenance of LAF Scope: This SOP is relevant for Operation, Calibration, Cleaning and Maintenance of LAF in Microbiology Laboratory. Responsibility: Chemist or above of Microbiology Laboratory. Head – Microbiology Section. Accountability: Head – Quality Control. …

SOP on Maintenance and usage of Reference cultures Objective: SOP on Maintenance and usage of Reference cultures. Responsibility: Officer or above of Microbiology Laboratory: Accountability: Head – Microbiology section. Head – Quality control. Procedure Procurement of Lyophilized Cultures Reference Cultures can be procured from following suppliers: ATCC: American Type Culture …

Market complaints and product recall DEFINITION: A ‘Complaint’ simply designates, that something is wrong or not good enough. Generally in the pharmaceutical industry, complaints are regarding the quality of drug products. A complaint shows customer dissatisfaction about a product and consequently, about a company. Principle: All complaints and other information …

Rubber Bung Processor Cum Sterilizer • HPHV Steam Sterilizer is used for sterilization of liquid, Hard and Hard Porous Material, Glass ware, drugs and surgical instrument used a pharmaceutical. It is also used For Sterilization of containers, vessels, linen, rubber articles culture media etc. • Provide with Sliding doors with …

Cleaning of Factory Footwear Objective To lay down a procedure for Cleaning of Factory Footwear.  Scope This Standard Operating Procedure is applicable for cleaning of factory footwear in the formulation plant. Responsibility Housekeeping personnel is responsible to follow the procedure mentioned in SOP. HR Department is responsible for implementation of …

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 …

Sterilization Process Controls Inspectional Objectives Confirm that the sterilization process was validated by reviewing the validation study. Review the specific procedure(s) for the sterilization process selected and the methods for controlling and monitoring the process. Verify that the process is controlled and monitored. If review of the Device History Records …

Dry Powder Injection Majority of drugs show the problem of poor solubility, whether in the case of their analytical estimations or in the field of liquid dosage forms in the form of solutions. Commonly used organic solvents for spectrophotometric analysis of water insoluble drugs include methanol, ethanol, chloroform, benzene, dichloromethane, …

The injectable dry filling area is a completely sterile area of the company that is a strictly controlled area. The high-level alertness is mandatory to main the atmospheric condition in the filling area of the dry powder filling area of Injectable. Every step in the production area requires a written …

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) …