Batch Manufacturing Record - Capsule

M/s (Name and address of the company) __________________________________
Name of the product __________________________________________________
(Trade name, if any)
(MFR No.) __________________________________________________________
(Batch No.) ____________________________________ Capsule size __________
(Batch size.) ____________________________________ Colour _______________
Date of Expiry _______________________________________________________
Date of commencement ________________________________________________


       Sr.No.
Ingredients
Standards
Q/C Report No.
Label Claim
Quantity Required
Quantity actually used
Remarks
1
2
3
4
5
6
7
8












TOTAL
Raw material initially weighed and measured by _____________________________
(Attach requisition/issue slip duly signed by stores personnel)
Weights counter checked by ____________________________________________
I certify that all the equipment and machinery to be have been examined by me and have found clean.
                                                                        
     
                                                                                                                                       Sign.
Mixing
Date
Time
Humidity
Temp.



Average weight of capsules _____________________________________________
Average weight per capsule ____________________________________________
Permissible weight variation limit _________________________________________

Date
Time
Filling Started
Filling Stopped












Date and time polishing commenced._____________________________________________
Date and time polishing stopped. ________________________________________________
Result of testing/analysis of
  bulk finished product ________________________________________________________
                                       
                                                                                                                   (Status, Receipt No.& Date)

PACKAGING

Packaging Description ________________________________________________________
Precoding of labels and printed packaging material examined & verified by  ________________________________________________________________
                                               (attach specimen)
No. of precoded
             I.      Labels received ________________________________________________________
          II.      Printed packaging material received _______________________________________


Date
Start. time
Clos. time
Name of person responsible for

    Stripping                   Other package
Stripping   Checking           Counting &
                                            filling in boxes
                                            




 


Total Quantity packed _________________________________________________
Date of completion ____________________________________________________
Qty. collected as samples by Q/C Department ______________________________


Reconciliation of labelling & Packaging Materials
Labels
Foil
Cartons
Requisitioned/Received
Used
Returned
Destroyed
Destroyed on
Destroyed by




Actual yield _________________________________________________________
Theoretical yield _____________________________________________________
Whether within limits __________________________________________________
Q/C Report of finished product __________________________________________
(Status No. & date and release order) _____________________________________


Sign.of Supervisor
(approved technical staff)

Date of release ______________________________________________________
Qty. released ________________________________________________________
Date of transfer of finished ______________________________________________
Product to warehouse _________________________________________________


Counter signed _________________________
                                                                   HEAD OF QUALITY CONTROL DEPARTMENT

Comments

Post a Comment

Popular posts from this blog

PLANT LAYOUT FOR CAPSULE MANUFACTURING DEPARTMENT & MANUFACTURING PROCESS

Image
PLANT LAYOUT  FOR CAPSULE MANUFACTURING DEPARTMENT: ENVIRONMENT CONDITION FOR CAPSULE FILLING AREA Humidity:          Not more than 35% RH Temperature:    Not more than 25% Area of each room, position of equipments, washing, drying, and sanitary facilities must be in accordance with GMP. MANUFACTURING PROCESS: CHEMCAPS Limited is an India based young and dynamic organization engaged in the manufacture and export of 'empty hard gelatin capsules' under the brand name of 'Chemlock' for discerning customers around the globe. COMPOSITION                                     Gelatin                                     Water                                     Colorants                                     Opecifier (TiO2 Dyes and Other)                                     Preservative MANUFACTURING OF HGC SHELL: SFR-901 FULLY AUTOMATIC CAPSULE MACHINE: FEATURES OF SFR-901 Ø   The Safrroys SFR-901 mod
Keep reading

ANTIOXIDANTS: In Pharmaceutical Formulation

Image
Introduction: Chemically they are reducing agents. They oxidize themselves and prevent oxidation of API. A substance that inhibits oxidation is called antioxidants. The effectiveness of antioxidant can depend on the concentration used and pH of solution. Examples:  Ascorbic acid,  butylated hydroxy anisole (BHA),  butylated hydroxyl toluene (BHT) Oxidation is a chemical reaction involving the loss of electrons or an increase in oxidation state. Oxidation reactions can produce free radicals. In turn, these radicals can start chain reactions. When the chain reaction occurs in a cell, it can cause damage or death to the cell. Antioxidants terminate these chain reactions by removing free radical intermediates, and inhibit other oxidation reactions. The following are some of the qualities of an ideal anti-oxidant: It should be readily soluble or dispersible in the medium. It should be effective in low concentration. It should be non-toxic. It should be non-irrita
Keep reading

3. Development of working hypothesis:

Image
After extensive literature survey, researcher should state in clear terms the working hypothesis or hypotheses. Working hypothesis is tentative assumption made in order to draw out and test its logical or empirical consequences. As such the manner in which research hypotheses are developed is particularly important since they provide the focal point for research. They also affect the manner in which tests must be conducted in the analysis of data and indirectly the quality of data which is required for the analysis. In most types of research, the development of working hypothesis plays an important role. Hypothesis should be very specific and limited to the piece of research in hand because it has to be tested. The role of the hypothesis is to guide the researcher by delimiting the area of research and to keep him on the right track. It sharpens his thinking and focuses attention on the more important facets of the problem. It also indicates the type of data required
Keep reading

Facebook Page

Knowledge of Pharma