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Product

During the manufacturing of products, there are different stages like Final mixing, compression startup, compassion complete, coating, finish stage, and stability studies, etc Product SOPs will cover these topics in this category of pharmaceuticals.

GMP Questionnaire for Excipients

GMP Questionnaire for Excipients

Raw Material, General SOPS, General Topics, Microbiology, Product, Production, Quality Assurance, Quality Control, SOPs, Testing Methods
A Good Manufacturing Practice GMP Questionnaire for Excipients is a tool used to assess and qualify excipient suppliers to ensure compliance with regulatory standards and quality requirements. Part I: To be Completed by Supplier A) Contact Details Name: Address: Postal Code, City: Country: Telephone / fax / E-mail: Contact Person: Is your company the subsidiary of another company or corporation? Yes No If yes, please state name of parent company: Number of local employees: What services do you offer? (enclose a description, if applicable) Is your company certified according to MP (if yes, please enclose certificate) Yes No Part II: To be Completed by Manufacturer Only I confir...
Determining Shelf Life And Stability Testing Programme

Determining Shelf Life And Stability Testing Programme

Quality Assurance, General Topics, Product, Production, Quality Control, SOPs
Standard Operating Procedure for Determining Shelf Life And Stability Testing Programme Determining Shelf Life And Stability Testing Programme is the stability testing programmed for all pharmaceutical products manufactured at Company facility confirm the stability of the products and compatibility. PURPOSE To describe the stability testing programmed for all pharmaceutical products manufactured at Company facility. To confirm the stability of the products and compatibility with its container, while stored in accordance with labeling conditions and time, and with respect to product degradation. Pharmaceutical products will be tested at designated intervals for certain physical, chemical and microbiological properties. To collect scientific evidence based on test results to d...
Amlodipine Besylate and Olmesartan Medoxomil Tablet Testing Method

Amlodipine Besylate and Olmesartan Medoxomil Tablet Testing Method

Testing Methods, Product, SOPs
There are different methods available for Amlodipine Besylate and Olmesartan Medoxomil Tablet Testing Method, but here is a general overview of some common analytical methods: HPLC Method: High-Performance Liquid Chromatography (HPLC) is a widely used analytical method for the quantification of Amlodipine Besylate and Olmesartan Medoxomil in tablets. In this method, a liquid sample is passed through a column packed with stationary phase materials, and the components are separated based on their chemical and physical properties. The separated components are detected using a UV detector, and the amount of each component is calculated. Spectroscopic Method: UV-Visible spectrophotometry is a simple and cost-effective method for the quantitative analysis of Amlodipine Besylate and Olmesar...
Lamotrigine Tablet 25mg 50mg and 100mg Testing By UV and HPLC Method

Lamotrigine Tablet 25mg 50mg and 100mg Testing By UV and HPLC Method

Testing Methods, Product, SOPs
Testing Lamotrigine tablets (100mg) using UV (Ultraviolet) spectroscopy and HPLC (High-Performance Liquid Chromatography) are common methods Lamotrigine Tablet 25mg 50mg and 100mg Testing By UV and HPLC Method in pharmaceutical analysis to determine the concentration and purity of the active pharmaceutical ingredient (API) in the formulation. Here's a brief overview of how you can perform these tests: PURPOSE: To describes the procedure for analysis at in-process and finished stage of Lamotrigine Tablet 25mg 50mg and 100mg Testing By UV and HPLC Method. SCOPE: This SAP gives detailed outline for the finished product analysis of Lamotrigine Tablet 25mg 50mg and 100mg Testing By UV and HPLC Method and will cover In process testing activities on physical, chemical & instrumental basis...
Clopidogrel 75mg Tablet Testing by Ultraviolet (UV) Spectroscopy

Clopidogrel 75mg Tablet Testing by Ultraviolet (UV) Spectroscopy

Testing Methods, Product, SOPs
It seems like you are referring to the testing of Clopidogrel 75mg Tablet Testing by Ultraviolet (UV) Spectroscopy UV spectroscopy is a common technique used in pharmaceutical analysis to determine the concentration of a substance in a sample based on its absorption of ultraviolet light. However, the specific details about the testing of Clopidogrel 75mg Tablet using UV spectroscopy, such as the methods, results, or any ongoing studies, would require access to recent research papers or publications in the field of pharmaceutical analysis. PURPOSE : To describes the procedure for analysis at in-process and finished stage of clopidogrel 75mg Tablet. SCOPE: This SAP gives detailed outline for the finished product analysis of clopidogrel 75mg Tablet and will cover In process testing activi...
Atorvastatin Tablets Finish Product Testing Procedure By UV and HPLC Method

Atorvastatin Tablets Finish Product Testing Procedure By UV and HPLC Method

Testing Methods, Product, SOPs
Atorvastatin Tablets Finish Product Testing Procedure By UV and HPLC Method like any other pharmaceutical product, is a crucial part of ensuring their safety, efficacy, and quality. Here's an overview of the typical testing procedures involved in the production and quality control of Atorvastatin tablets: It's essential to note that specific testing procedures may vary depending on the country, regulatory agency, and pharmaceutical company. Manufacturers must adhere to good manufacturing practices (GMP) to maintain the quality and consistency of their products. The goal of these testing procedures is to ensure that Atorvastatin tablets are safe, effective, and of high quality, providing patients with the expected therapeutic benefits while minimizing risks and maintaining product con...
Linezolid 600mg film-coated Tablets Finish Product Testing Procedure

Linezolid 600mg film-coated Tablets Finish Product Testing Procedure

Testing Methods, Product, SOPs
Linezolid 600mg film-coated Tablets Finish Product Testing Procedure, like other pharmaceutical products, is a critical step in ensuring their safety, efficacy, and quality. Below is an overview of the typical testing procedures involved in the production and quality control of Linezolid tablets: It's essential to note that specific testing procedures may vary depending on the country, regulatory agency, and pharmaceutical company. Manufacturers must adhere to good manufacturing practices (GMP) to maintain the quality and consistency of their products. The goal of these testing procedures is to ensure that Linezolid 600 mg tablets are safe, effective, and of high quality, providing patients with the expected therapeutic benefits while minimizing risks and maintaining product consiste...
Rifaximin 550 mg Tablets Finish Product Complete Testing Procedure

Rifaximin 550 mg Tablets Finish Product Complete Testing Procedure

Testing Methods, Product, SOPs
The Rifaximin 550 mg Tablets Finish Product Complete Testing Procedure, like other pharmaceutical products, is essential to ensure their safety, efficacy, and quality. Below is an overview of the typical testing procedures involved in the production and quality control of Rifaximin tablets. The goal of these testing procedures is to ensure that Rifaximin 550 mg tablets are safe, effective, and of high quality, providing patients with the expected therapeutic benefits while minimizing risks and maintaining product consistency. Please note that specific testing procedures may vary depending on the country, regulatory agency, and pharmaceutical company. Manufacturers must adhere to good manufacturing practices (GMP) to maintain the quality and consistency of their products. PURPOSE: T...
Procedure for Analysis at the In-process and Finished Stage of the Mecobalamin 500mcg Tablet

Procedure for Analysis at the In-process and Finished Stage of the Mecobalamin 500mcg Tablet

Testing Methods, Product, SOPs
Analyzing Mecobalamin 500mcg tablets at both the in-process and finished stages is essential to ensure the quality, safety, and efficacy of the product. The analysis involves various tests and quality control measures. Below is a general Procedure for Analysis at the In-process and Finished Stage of the Mecobalamin 500mcg Tablet Have the data and results reviewed by authorized personnel, including quality control and quality assurance teams, before approving the product for release or further processing? Always follow approved procedures and protocols specific to your laboratory and adhere to Good Manufacturing Practices (GMP) to ensure the accuracy and reliability of the analysis. This procedure is a general guideline and may need to be adapted based on the specific requirements and...
SOP for Finished Product Analysis of Misoprostol 200mcg Tablet by HPLC Method

SOP for Finished Product Analysis of Misoprostol 200mcg Tablet by HPLC Method

Testing Methods, Product, Quality Control, SOPs
For misoprostol, identification, assay, and related substances were considered essential, given the link to efficacy and the known instability of the product. SOP for Finished Product Analysis of Misoprostol 200mcg Tablet by HPLC Method due to the low ratio of API content to tablet mass and therefore higher risk of non-homogeneity within batches, content uniformity was included. Dissolution or disintegration was not included as misoprostol is a highly soluble substance (19), and anecdotally these parameters are rarely found out of specification (OOS) for misoprostol products. Misoprostol tablets were analyzed for the selected parameters using the methods and specifications described in the International Pharmacopoeia PURPOSE: To describe the procedure for analysis at the in-process and f...