LINE CLEARANCE CHECKLIST OF AREA & EQUIPMENT GRANULATION

LINE CLEARANCE CHECKLIST OF AREA & EQUIPMENT GRANULATION Dosage Form: Tablet Date / Time: Product: Batch No.  : Previous product: Batch No.  : Stage areas / room & equipment Checks Checked by Production Date & Time Counter checked By Quality Assurance Date & Time GRANULATION [Released / Not Released / Hold / Rejected / Not … Read more

LINE CLEARANCE CHECKLIST OF AREA & EQUIPMENT FOR BINDER PREPARATION

LINE CLEARANCE CHECKLIST OF AREA & EQUIPMENT FOR BINDER PREPARATION Dosage Form: Date / Time: Product: Batch No.  : Previous product: Batch No.  : Stage areas / room & equipment Checks Checked by Production Date & Time Counter checked By Quality Assurance Date & Time BINDER PREPARATION [Released / Not Released / Hold / Rejected … Read more

LINE CLEARANCE CHECKLIST FOR DISPENSING AREA

LINE CLEARANCE CHECKLIST  FOR DISPENSING AREA Dosage Form: Date / Time: Product: Batch No.  : Previous Product: Batch No.  : Dispensing Room: Sr. No. Check points Observations Done By Checked by Verified By QA Production Warehouse DISPENSING AREA [Released / Not Released / Hold / Rejected / Not Applicable] Room Identification number: 1 Ensure the … Read more

Flow Chart and Manufacturing Procedure of Nimesulide Tablets

Flow Chart and Manufacturing Procedure of Nimesulide Tablets Bill of Materials Ingredient Pharmacopoeial Status Pharmaceutical role Nimesulide Ph.Eur Active Lactose Monohydrate Ph.Eur. Diluent Croscarmellose Sodium Ph.Eur Disintegrant Silica, Colloidal Anhydrous Ph.Eur. Glidant Maize Starch Ph.Eur Diluent Povidone (K-30) Ph.Eur. Binder Docusate Sodium Ph.Eur. Surfactant Polysorbate 80 Ph.Eur. Surfactant Hydrochloric Acid,Concentrated Ph.Eur. pH Adjusting agent Water, … Read more

Non Conformance and Failure Investigation Checklist in pharmaceutical Products

Non Conformance and Failure Investigation Checklist in pharmaceutical Products Product Name                :                                           Batch No.  :                            … Read more

OOS Investigation Checklist

OOS Investigation Checklist Checklist for investigation of out of specification Sampling: Is performance against written procedure carried out? Are the cleaned sampling equipments used? Are the cleaned containers used for collection of samples? Is the sample integrity maintained until testing? Is composite sample prepared correctly? SAMPLE PREPARATION: Is correct weighing from correct portion of sample … Read more

DATA INTEGRITY – QUESTIONS AND ANSWERS

DATA INTEGRITY – QUESTIONS AND ANSWERS 1. Please clarify the following terms as they relate to CGMP records: 1.A) What is “data integrity”? Data integrity refers to the completeness, consistency, and accuracy of data. Complete, consistent, and accurate data should be attributable, legible, contemporaneously recorded, original or a true copy, and accurate (ALCOA). 1.B)What is “metadata”? Metadata is … Read more

Data Integrity Guidance in Pharmaceuticals

Data Integrity Guidance Good data management practices influence the integrity of all data generated and recorded by a manufacturer and these practices should ensure that data is accurate, complete and reliable. The organisational culture should ensure data is complete, consistent and accurate in all its forms, i.e. paper and electronic Organisations are not expected to implement a forensic … Read more

Training Requirements for Audit and Routine Practices in Pharmaceuticals

Training Requirements for Audit and Routine Practices in Pharmaceuticals Each person engaged in the manufacture, processing, packing, or holding of a drug product shall have education, training, and experience, or any combination thereof, to enable that person to perform the assigned functions. Training shall be in the particular operations that the employee performs and in … Read more

Personal Hygiene Checklist for Audit and Routine Practices in Pharmaceuticals

Personal Hygiene Checklist for Audit and Routine Practices in Pharmaceuticals A high level of sanitation and hygiene should be practiced in every aspect of the manufacture of drug products. The scope of sanitation and hygiene covers personnel, premises, equipment and apparatus, production materials and containers, products for cleaning and disinfection, and anything that could become … Read more

Manufacturing Procedure of Ornidazole Tablets

 Manufacturing Procedure of Ornidazole Tablets   Bill of Material Ingredient Pharmaceutical role Ornidazole Active Microcrystalline Cellulose Diluent Lactose Monohydrate Diluent Silica, Colloidal Anhydrous Surfactant Povidone (K-30) Binder Water, Purified Vehicle Sodium Lauryl sulphate Surfactant Talc Granular former Magnesium Stearate Lubricant Croscarmellose Sodium Disintegrating Opadry Green Coloring Agent Manufacturing Procedure  Step – I:-Sift, Lactose Monohydrate, Silica, … Read more

MANUFACTURING PROCESS FLOW CHART (Coated tablets)

MANUFACTURING PROCESS FLOW CHART (Coated tablets)     Thank you for visit and for more pharma updates click here – https://pharmaguidances.com

MANUFACTURING PROCESS FLOW CHART (Uncoated tablets)

MANUFACTURING PROCESS FLOW CHART (Uncoated tablets)   Thank you for visit and for more pharma updates click here – https://pharmaguidances.com  

Manufacturing Procedure and Flow chart of Metformin Hydrochloride Extended – Release Tablets USP 1000 mg

Manufacturing Procedure of Metformin Hydrochloride Extended-Release Tablets USP 1000 mg     Bill of Material: Batch Size:- 100000 Tablets Ingredient Standard Quantity  Per batch In kg METFORMIN HYDROCHLORIDE 100.60* CARMELLOSE SODIUM 10.00 PURIFIED WATER 18.60 HYPROMELLOSE 26.00 CELLULOSE,MICROCRYSTALLINE (DIRECTLY  COMPRESSIBLE,PH 102) 9.5 MAGNESIUM STEARATE 1.5 POVIDONE 1.5 SILICA , COLLOIDAL .ANHYDROUS 1.5 * Given quantity of Metformin … Read more

CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS – GENERAL

CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS – GENERAL Sec. 210.1-Status of current good manufacturing practice regulations (a)  The minimum current good manufacturing practice for methods to be used in the facilities or controls to be used for, the manufacture, processing, packing, or holding of a drug to assure that … Read more

Validation of Sterilization Process in Autoclave

Validation of Sterilization Process in Autoclave VALIDATION PROTOCOL                  Validation of Sterilization  Process in Autoclave (Loaded chamber)  Purpose : To provide the procedures to be followed for study of heat  distribution studies in loaded chamber of Autoclave.  Scope :  This procedure is applies to all Autoclaves used to sterilize Containers or Equipment’s used for aseptic processing of … Read more

Procedure for measurement of fill weight during batch filling

Procedure for measurement of fill weight during batch filling Objective: To lay down the procedure for measurement of fill weight during batch filling. Scope: This SOP is applicable for measurement of fill weight during batch filling in Injectable department. Responsibility: Operators/Technician – Responsible for measurement of fill weight during batch filling. Executive /Officers production – … Read more

Manufacturing Process Development as per ICH -Q11

Manufacturing Process Development as per ICH -Q11 The approaches to developing and understanding the manufacturing process of the drug substance, and  provides guidance on what information should be provided in Module 3 of the Common Technical Document (CTD) Sections 3.2.S.2.2 –3.2.S.2.6 (ICH M4Q). All the aspects of development and manufacture that pertain to drug substance, including the presence … Read more

Qualification For Stability Chamber ( STABILITY DATA ACQUSITION SOFTWARE)

Qualification For Stability Chamber ( STABILITY DATA ACQUISITION SOFTWARE) Purpose The purpose of this Qualification Plan (QP) is to define the Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) Testing activities for the qualification of WALK IN CHAMBER, STABILITY DATA ACQUISITION SOFTWARE to be deployed at Quality Unit, for the users in the Quality Control/ … Read more

DISINFECTANT VALIDATION

DISINFECTANT VALIDATION TABLE OF CONTENTS  Section No Topics Page No 1.0 Protocol Approval 2.0 Objective 3.0 Acceptance Criteria 4.0 Responsibilities 5.0 Validation Methodologies 6.0 Evaluation of test Result 7.0 Re-validation Frequency 8.0 Documentation 9.0 Conclusion PROTOCOL APPROVAL   Name /  Designation  Signature  Date  Prepared By Microbiologist      Checked By  Microbiology Manager. Quality Control  Approved By … Read more