PharamaIndustry

 

Labelling API in Production Indusrry:

Containers for APIs and API Intermediates should bear labels that give at least the following 

information: - The name of the material, - Site material identification code, - Amount of material, - The batch or lot number, - The expiry date (if applicable), - Any special storage or handling conditions, and

- The manufacturing site and contact information. 

 General Requirements for Labels 

- Labels should be clear, unambiguous, and permanently affixed to containers 

- Labels should follow an approved Site format, bear a label code number with revision  code

-






labelling in pharama Industry:

The information on the label should be indelible 

 Minimum Requirements for Label Content - Identification Name(s), including International Nonproprietary Name (INN) if Applicable.

- Grade (e.g. Sterile, Injectable, Veterinary) if applicable 

- Site article number 

- Manufacturer or re-packer lot number or batch number 

- Pharmacopoeia reference (e.g. USP, BP, EP, JP) if applicable 

- If a controlled substance appropriate codes must be included 

- Stability, Storage or Handling Information 

- Expiry date, if one exists; if a retest interval exists, a retest date may be included on 

the label or the certificate of analysis 

- Special storage or shipping conditions – based on formal stability studies and per 

- Handling precautions and safety information – may be presented on a separate label - Contact Information  


Comments

Post a Comment

Popular posts from this blog

Pharamaaceutical Industry & Life Sciences

Image
  Deht and Ceht in Pharma Industry: Dirty Equipment Hold Time   (DEHT): Elapsed time between the end of a manufacturing / packaging process аnd execution of the complete cleaning procedure. Clean Equipment Hold Time (CEHT): Elapsed time between the end of a complete cleaning process and introduction of product for the next use. A: The rational to CHT is described in the answer to Q2 and Q2a. The question on how many days you should take into consideration is predominantly depending on your internal processes. The maximum expected clean hold time should be used for the study. To give a simple example: consider you make a cleaning of an object on Friday and have no manufacturing at the weekend. Probably the next Monday is a public holiday and so the maximum clean hold time after cleaning is 4 days (depending on when you start manufacturing using the cleaned equipment).
Read more

Pharamceutical Industry & Life Sciences

Image
Importent Points in Pharama Industry: Handling specification  impurities Trial Batch(RD & A R&D) Critical Process Parameter In Process R&D ,A R&D  small scale batches Design Qualification Area(Plant) Process Validation : Critical Parameter,How Many Batches, Impurities,Yield,Quality. Validation Protocol: Critical Process Parameter,Specification ,Yield,Quality, Equipment, Revolidation: Process Major Changes ,Equipment Changes,Raw Material Changes. Design Qulification, Installation Qualification,Operational Qualification,Performance Qualification Before three batch execution of manufactureing based on Customer. \
Read more

Pharamaceutical Industry & Life Sciences

Image
  Some Importent Points of Pharama Industry: Note down points verification process  men Machine/equipment/instrument/day tank Material Method Development Process Method of Analysis Utilities these all observed batch fail time.  Swan--- soil water air nature. Permits to work: Form's User department check list Engineering Services Check list Safety Recomended Plant Head Work Cleareance close with in 90 days
Read more