Sunday 15 September 2013

SOP for Preparation, qualification, Usage and destruction of working



I.                   PURPOSE

To define the procedure for Preparation, qualification, Usage and destruction of working standards.

II.                SCOPE

This SOP is applicable for all products manufactured at….

III.             RESPONSIBILITY

Assistant - QC, Executive - QC

IV.             ACCOUNTABILITY
Manager - QC
V.                PROCEDURE
1.0              Selection of batch for working standard Preparation
1.1              QC shall select a recently manufactured, approved plant batch, containing less impurities and high potency.
1.2              QC shall send the internal communication to production for required quantity.
2.0              Selection of reference standards
2.1              It is the prime responsibility of an analyst to update the pharmacopoeia reference standards as per current catalog.
2.2              Use pharmacopoeia reference standard for compendial products.
2.3              For non-pharmacopoeial products use   R&D working standard.
3.0              Standardization of working standards
3.1              After getting the sample from production QC shall analyse the sample   as per pharmacopoeia tests by using concern pharmacopoeial reference standard.
3.2              If the sample is non-pharmacopial product, analyse the sample as per In house specification provided by R&D by using R&D working standard.
3.3              For working standard analysis, the assay & water (or Loss On Drying) shall be carried out in duplicate. The working standard qualification shall be as per predetermined specification other than assay and water (or Loss On Drying) the remaining tests shall be analyzed in once for working standard.
3.4              QC shall enter the analytical data in working standard preparation Test protocol as per Format No. F01/SOPQC018-00
3.5              After complete analysis, QC shall enter the results in working standard certificate of analysis as per Format No. F02/SOPQC018-00
4.0              Working standard vials filling
4.1              After approval of working standard by Manger –QC, concerned QC analyst shall take about 30 vials and fill nearly 3.5 to 4.5 gm in each vial.
4.2               Use hand gloves while filling the material in to the vials.
5.0              Usage and validity of working standard
5.1              One vial shall be used for one month, after completion of one month if quantity is remained in the vial, destroy the remaining quantity.
5.2              Maintain working standard usage record as per Format No. F03/SOPQC018-00.
5.3              Expired working standards destroyed and maintain the destruction record as per the Format No.F04/SOPQC018-00.
5.4              One-year shelf life shall be assigned for working standard from qualification
            date .

6.0              Storage and maintenance of working standards
6.1              Working standard and reference standards should be preserved in tightly closed glass vials and label properly.
6.2              After every weighing, close the vial and seal it and keep it in desiccator.
6.3              Store the vials in the desiccator containing active silica and keep it in refrigerator.
7.0              Working standard Numbering system
W      PP   XX    M   Y

                                                       Year code      
                                                        Month code in alphabetical
                                                        Sequential Number
                                                        Product Code
                                                        Working standard

            8.0       After vial filling, stick the label on the each vial as per the Format No. F05/SOPQC018-                00

           

Working standard

W.S.Name : 
W.S.No.    :                                          Vial No.
USP R.S.Lot No.     :                           Prepared on:
Potency                    :                           Prepared by :
(as such)                                               Checked by :

Water content   :

Storage Condition:
 
      Note: If Ref.std. is obsolete before working standard validity date or any pharmacopoeia            changes occur , qualify new working standard with new Ref.std.




                                   
                                                                                            





            9.0       List of Formats
Format No.
Purpose
F01/SOP QC018-00
Working Standard testing protocol
F02/SOP QC018-00
Working Standard Certificate of analysis
F03/SOP QC018-00
Working Standard Usage record
F04/SOP QC018-00
Working Standard destruction record
F05/SOP QC018-00
Working Standard vial label
                        
VI.     REVISION SUMMARY
Version No.
Revised on

Reason for Revision


00


NA

NA

 
END OF THE DOCUMENT

4 comments:

  1. I find something in herbal medicine good to share on here with anyone suffering from the disease such as HIV, Herpes, Hepatitis or Chronic Lyme Disease,Parkinson's disease,Schizophrenia,Lung Cancer,Breast Cancer,Colo-Rectal Cancer,Blood Cancer,Prostate Cancer,siva.Fatal Familial Insomnia Factor V Leiden Mutation ,Epilepsy Dupuytren's disease,Desmoplastic small-round-cell tumor Diabetes ,Coeliac disease,Creutzfeldt–Jakob disease,Cerebral Amyloid Angiopathy, Ataxia,Arthritis,Amyotrophic Lateral Scoliosis,Fibromyalgia,Fluoroquinolone Toxicity
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    Dementia.
    Lupus as well.Dr Itua herbal made cure my HIV and gave me hope that he can cure all types of diseases I believed him) I do the best of myself that I can do, I went for a program in west Africa about fashion on another side I was HIV positive. I walk through a nearby village for our program schedule then I found a signage notice that says Dr Itua Herbal Center then I asked my colleagues what all about this very man called Dr Itua, She told me that he's a herbal doctor and he can cure all kind of disease i walked to him and explain myself to him as I'm a strangler out there he prepared me herbal medicine and told me how to drink it for two weeks, when I get to my hotel room I take a look at it then says a prayer before I drank it not knowing after two weeks I went to test and I found out I was negative I ran to him to pay him more but he refuses and says I should share his works for me around the globe so sick people can see as well. I'm writing a lot about him this season so that is how I was cured by drinking Dr Itua herbal medicine, He's A caring man with godly heart. Well - everything I decided all go through for me well and how you're going to treat this new aspect to your life. You don't have to suffer alone, and it's okay to ask for help. It also doesn't have to be a constant demon, as you'll get to know your body and yourself in a much deeper way than most people. Take advantage of this, as it will help you appreciate Africa Herbal Made.
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    ReplyDelete
  2. I'm so exited to share my testimonies about the Good Work of Dr. Udebhu who get me cured from herpes simplex virus (HSV1&2) with his herbs, I never thought that I will live on earth before the year runs out. I have been suffering from herpes, I had spent a lot of money going from one Hospital to another looking for way to get rid of this disease, the hospital have been my home everyday residence. Constant checks up have been my hobby not until this faithful day, I was searching
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     Herbs, quickly I copied his email just to give him a test I spoke to him, he told me that he is going to provide the herbal cure to me, which he
    did, after i receive his herbs and i take it as instructed i was cure permanently from herpes my herpes disease was gone. so I decided to share my testimony, that nothing is impossible with God, God use a man to healed me. No matter what you are passing through, no matter how deadly the sickness is and no matter what the situation is God that did mine is still going to do yours, people suffering from herpes, brain tumor, kidney disease, pcos, AIDS, ALS,copd, asthma, athritis,herpes, Cancer,Hpv, any kind of disease, you can rich him now via ? Gmail address: drudebhuherbalhome@gmail.com or whatsapp +2349051254152  

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  3. HIV/AIDS is a serious and recurring disease which can't be cure through drugs or injections by an American doctors but the best way to deal with HIV/AIDS is by taking natural herbs medicine for it, I have red about DR JAMES the great herbalist doctor who cured me from HIV/AIDS with his powerful herbal medicine. I contacted him to know how he can help me and he told me never to worry that he will help me with the natural herbs!After 2 days of contacting him, he told me that the cure has been ready and he sent it to me via UPS SPEED POST and it got to me after 4 days i used the medicine as he instructed me (MORNING and EVENING) and i was cured!it's really like a dream but I am so happy! for the people suffering from HIV/AIDS and other diseases like Rectum effects, intestine damage, bowel obstruction, Ovarian disease, Cancer, hypothyroidism, Herpes, COPD, HIV, Arthritis, Lyme disease,Hpv, Infections,Liver Disease, Autoimmune Diseases, Parkinson's disease,Lupus,Nephrology and Hypertension, Neurology, Obstetrics, Gynecology, and Women's Health, Oncology, Pediatrics, Pulmonary, ACUTE MYELOFIBROSIS, ALZHEIMER's symptoms, BREAST CANCER, DIABETES, HAIR LOSS AND HAIR TREATMENT, KIDNEY DISEASES, LEUKEMIA, MYELOID LEUKEMIA, STEM CELL TREATMENT
    should contact him for his herbal medicine because i am a living testimony and i was cured of HIV/AIDS and his medicine is legit. I sent him what he requested and he sent me his medicine which I took for 2 good weeks and today I am out here with a negative result. When I went for the test I was so happy after taking his herbal medication I paid homage to his country to celebrate with him on his African festival which he told me it usually happens every year. you can reach him through VIA E-mail drjamesherbalmix@gmail.com or whatsapp number:+2348152855846

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  4. I’m Katty morgan from the States.I want to use this medium to appreciate Mrs Julia for coming on the platform to share her experience with Dr osuma i have been online looking for a genuine remedy to my illness of 5 years Hiv until i read Mrs Julia  post.As we all know these days the truth is rear so i didn’t want to believe Mrs Julia until a second taught asked me to.I contacted Dr osuma as directed by Mrs Julia and follow the procedures and everything worked out in a brief.I thought there was no actual cure for Hiv until a little trial convinced me.i was cured after 3 weeks of usage of Dr osuma great herbal medicine,he has a cure for what so ever health challenging issue HIV,TB,VERTEBRAL ISSUE,CANCER,DIABETES,ISCHEMIC DISEASES,STROKE,RESPIRATORY INFECTIONS,PULMONARY DISEASE,ALZHEIMER”S DISEASE,DEHYDRATION,CIRRHOSIS ETC.You can contact him via his Email (drosumaherbalcure@gmail.com)

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