Home / Audit and Guideline / Audit and Routine Checklist

Audit and Routine Checklist

Equipment in Pharma company as per USFDA

Equipment in Pharma company as per USFDA Equipment design, size, and location (§ 211.63) in Pharma company Equipment used in the manufacture, processing, packing, or holding of a drug product shall be of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and for its …

Read More »

Production and Process Controls in Pharma industry as per USFDA

Production and Process Controls in Pharma industry as per USFDA Written procedures; deviations (21 CFR 211.100). Charge-in of components (21 CFR 211.101). Calculation of yield (21 CFR 211.103). Equipment identification (21 CFR 211.105). Sampling and testing of in-process materials and drug products (21 CFR 211.110). Time limitations on production (21 …

Read More »

Definitions as per 21 CFR 210 (USFDA) in Pharma company

Definitions as per 21 CFR 210 (USFDA) in Pharma company (a) The definitions and interpretations contained in section 201 of the act shall be applicable to such terms when used in this part and in Parts 211 through 226 of this chapter for Pharma company. (b) The following definitions of …

Read More »

Buildings and Facilities in pharma industry as per USFDA

Buildings and Facilities in pharma industry Design and construction features in pharma industry  (a) Any building or buildings used in the manufacture, processing, packing, or holding of a drug product shall be of suitable size, construction, and location to facilitate cleaning, maintenance, and proper operations. (b) Any such building shall have adequate space for the …

Read More »

Guideline for Hold-Time Studies of Tablets

Hold-Time Studies Guideline These guidelines focus primarily on aspects that should be considered in the design of the hold-time studies during the manufacture of non-sterile solid dosage forms. Many of the principles described here also apply to other dosage forms such as liquids, creams and ointments. These guidelines do not …

Read More »

All Post URL of Drugs formulations

All Post URL of Drugs formulations Tablets MFR of Albendazole Tablets – (drugsformulations.com) MFR of Alfacalcidol & Calcium Carbonate Tablets (drugsformulations.com) MFR of Sildenafil Citrate Tablets (drugsformulations.com) MFR of Paracetamol & Dicyclomine HCl Tablets – (drugsformulations.com) MFR of Dextromethorphan, Bromhexine, Chlorpheniramine Maleate & Guaifenesin  Tablets (drugsformulations.com) Dextromethorphan (drugsformulations.com) Spiramycin Tablet (drugsformulations.com) MFR of Propranolol Hydrochloride …

Read More »

Pharmaguidances Whats App Groups

Pharmaguidances Whats App Groups Pharmaguidances   Pharma Post and Jabs     Pharma Vacancy Pharma Post and Jabs 2   Pharmaguideline   Pharmaguideline 2           MFR of SALBUTAMOL SULPHATE TABLET Pharmaceutical GuidanaceMr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical …

Read More »

Things to Do When FDA Staff Are on Site to Conduct an Inspection

The 10 Best — and 10 Worst — Things to Do When FDA Staff Are on Site to Conduct an Inspection FDA Expectations • FDA conducts inspections to assess compliance with applicable laws and regulations • FDA expects: – Investigators to conduct inspections in a reasonable manner – Industry to …

Read More »

Checklist in Quality control for Audit Preparation of FDA & USFDA

Checklist in Quality control for Audit Preparation of FDA & USFDA Personnel Organogram of Quality control departments List of Employee and education details Individual Job Description Training Record of Individual employee as per   individual Job Responsibility  and Training Log and training assessments records Analyst Qualification records as per  individual Job Responsibility and  …

Read More »

LINE CLEARANCE CHECKLIST FOR VACUUM CLEANER

LINE CLEARANCE CHECKLIST FOR VACUUM CLEANER Dosage Form: Date / Time: Product: Batch No.  : Previous Product: Batch No.  : Vacuum cleaner ID No.: Stage areas / room & equipment Checks Checked by Production Date & Time Counter checked By Quality Assurance Date & Time Vacuum cleaner Equipment ID No.: …

Read More »
free website promotion

Powered by themekiller.com anime4online.com animextoon.com apk4phone.com tengag.com moviekillers.com